The Tracker // October 2025
October 2025: 134 FDA device decisions
134 510(k) clearances and 0 original PMA approvals with a decision date in October 2025. Filter by panel, or search the page.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Oct 31, 25 | DEN240074510(k) | Pulsenmore ES | Pulsenmore, Ltd. | Radiology | SGJ |
| Oct 31, 25 | K250306510(k) | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | General Hospital | FRG |
| Oct 31, 25 | K250338510(k) | MSS - Humeral reverse liners extension | Medacta International S.A. | Orthopedic | PHX |
| Oct 31, 25 | K250358510(k) | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson and Company | Microbiology | PCI |
| Oct 31, 25 | K250917510(k) | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) | Shenzhen Sanping Image Technology Co., Ltd. | Gastroenterology, Urology | FGB |
| Oct 31, 25 | K251041510(k) | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | Actuated Medical, Inc. | Gastroenterology, Urology | FDS |
| Oct 31, 25 | K251381510(k) | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | Neurology | GXY |
| Oct 31, 25 | K251547510(k) | DESS Dental Smart Solutions | Terrats Medical SL | Dental | NHA |
| Oct 31, 25 | K252060510(k) | GREEN | Phasor Health, LLC | Neurology | HBE |
| Oct 31, 25 | K252074510(k) | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | Radiology | IYN |
| Oct 31, 25 | K252088510(k) | Firebird SI Navigation System | Orthofix US, LLC | Neurology | OLO |
| Oct 31, 25 | K252160510(k) | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | Neurology | OMB |
| Oct 31, 25 | K252412510(k) | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) | Applied Medical Resources Corporation | General, Plastic Surgery | GEI |
| Oct 31, 25 | K252427510(k) | Diode Laser Hair Removal Machine (GLD01) | Sanhe Meditech Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 31, 25 | K252442510(k) | Kii Structural Balloon Access System | Applied Medical Resources Corp. | Gastroenterology, Urology | GCJ |
| Oct 31, 25 | K252777510(k) | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | Orthopedic | MBH |
| Oct 31, 25 | K253501510(k) | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Indústria E Comercio Ltda | Dental | ELW |
| Oct 30, 25 | K243619510(k) | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | General, Plastic Surgery | ESW |
| Oct 30, 25 | K250325510(k) | BD Alaris Pump Infusion Set | Carefusion (Bd) | General Hospital | FPA |
| Oct 30, 25 | K250337510(k) | AiORTA - Plan | ViTAA Medical Solutions, Inc. | Radiology | QIH |
| Oct 30, 25 | K250632510(k) | Arctx Cool Catheter Set | Arctx Medical | Cardiovascular | PLA |
| Oct 30, 25 | K251531510(k) | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | Physical Medicine | IRP |
| Oct 30, 25 | K251686510(k) | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | Orthopedic | KWT |
| Oct 30, 25 | K251938510(k) | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | Dental | DZE |
| Oct 30, 25 | K252046510(k) | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | Cardiovascular | NRY |
| Oct 30, 25 | K252387510(k) | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | Diasorin Molecular, LLC | Microbiology | QOF |
| Oct 30, 25 | K252414510(k) | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Physical Medicine | OAP |
| Oct 30, 25 | K252430510(k) | Freeprint® denture flex | Detax GmbH | Dental | EBI |
| Oct 30, 25 | K252529510(k) | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120) | Boston Scientific Corporation | General, Plastic Surgery | GEX |
| Oct 30, 25 | K252607510(k) | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | Clinical Chemistry | JMT |
| Oct 30, 25 | K252752510(k) | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | General, Plastic Surgery | QAI |
| Oct 30, 25 | K253327510(k) | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | General, Plastic Surgery | ESW |
| Oct 30, 25 | K253376510(k) | OBSIDIO Conformable Embolic (M0013972101010) | Boston Scientific Corporation | Cardiovascular | KRD |
| Oct 29, 25 | K250316510(k) | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | Orthopedic | JDW |
| Oct 29, 25 | K250618510(k) | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | Neurology | NFO |
| Oct 29, 25 | K250882510(k) | SANSA HSAT | Huxley Medical | Anesthesiology | MNR |
| Oct 29, 25 | K251643510(k) | Synchfix EVT | Wright Medical Technology, Inc. (Stryker Corporation) | Orthopedic | HTN |
| Oct 29, 25 | K251772510(k) | Navilas Laser System 577sl (156691) | Od-Os GmbH | Ophthalmic | HQF |
| Oct 29, 25 | K251963510(k) | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Oct 29, 25 | K251985510(k) | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| Oct 29, 25 | K252314510(k) | Arthrex SutureTak Suture Anchor | Arthrex, Inc. | Orthopedic | MBI |
| Oct 29, 25 | K252390510(k) | Telescope Guide Extension Catheter | Medtronic, Ireland | Cardiovascular | DQY |
| Oct 29, 25 | K252393510(k) | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | Clinical Chemistry | MMI |
| Oct 29, 25 | K252416510(k) | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | Orthopedic | KWS |
| Oct 29, 25 | K252697510(k) | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | Gastroenterology, Urology | GCJ |
| Oct 29, 25 | K253153510(k) | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | General, Plastic Surgery | QAI |
| Oct 29, 25 | K253232510(k) | Seguin Annuloplasty Ring | ABBOTT MEDICAL | Cardiovascular | KRH |
| Oct 29, 25 | K253242510(k) | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | Radiology | PGY |
| Oct 29, 25 | K253283510(k) | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 29, 25 | K253314510(k) | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | Orthopedic | JWH |
| Oct 29, 25 | K253323510(k) | Protrieve Sheath | Inari Medical | Cardiovascular | QEW |
| Oct 29, 25 | K253345510(k) | JARVIS Diaphyseal Stem Standard | FH Industrie | Orthopedic | PHX |
| Oct 29, 25 | K253355510(k) | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | Dental | LRK |
| Oct 28, 25 | K250275510(k) | PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch | Baylis Medical Technologies, Inc. | General, Plastic Surgery | GEI |
| Oct 28, 25 | K251466510(k) | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. | Cardiovascular | JOW |
| Oct 28, 25 | K252165510(k) | ZIRCONOMER P | Shofu Dental Corporation | Dental | EMA |
| Oct 28, 25 | K252351510(k) | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | Orthopedic | MAX |
| Oct 28, 25 | K252376510(k) | Yomi S Robotic System | Neocis, Inc. | Dental | PLV |
| Oct 28, 25 | K252547510(k) | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | Radiology | LLZ |
| Oct 28, 25 | K252742510(k) | Navigated Instruments | Tyber Medical, LLC | Neurology | OLO |
| Oct 28, 25 | K253300510(k) | Fine Osteotomy | Bodycad Laboratories, Inc. | Orthopedic | HRS |
| Oct 28, 25 | K253399510(k) | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (Dba Philips Image Guided Therapy Device | Cardiovascular | OBJ |
| Oct 27, 25 | K250297510(k) | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | Neurology | GWO |
| Oct 27, 25 | K250520510(k) | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | Neurology | OLO |
| Oct 27, 25 | K251027510(k) | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | Radiology | QIH |
| Oct 27, 25 | K251331510(k) | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd. | Cardiovascular | DXN |
| Oct 27, 25 | K251824510(k) | Patriot Duo | Patriot Laser, LLC | General, Plastic Surgery | GEX |
| Oct 27, 25 | K251875510(k) | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | Microbiology | SAN |
| Oct 27, 25 | K252053510(k) | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd | General, Plastic Surgery | OHS |
| Oct 27, 25 | K252467510(k) | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | General Hospital | LYZ |
| Oct 27, 25 | K252629510(k) | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 27, 25 | K252630510(k) | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 24, 25 | K250345510(k) | Medline Bag Decanter | Medline Industries, LP | General Hospital | LHI |
| Oct 24, 25 | K250687510(k) | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | Dental | MUH |
| Oct 24, 25 | K250696510(k) | AccuCheck | Manteia Technologies Co., Ltd. | Radiology | IYE |
| Oct 24, 25 | K250904510(k) | Atalante X | Wandercraft SAS | Physical Medicine | PHL |
| Oct 24, 25 | K251059510(k) | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | Radiology | QIH |
| Oct 24, 25 | K251312510(k) | Vesalio Peripheral System | Vesalio, Inc. | Cardiovascular | QEZ |
| Oct 24, 25 | K251372510(k) | VersaD Delivery Catheter | Unity Medical, Inc. | Cardiovascular | QJP |
| Oct 24, 25 | K251710510(k) | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | Radiology | IZL |
| Oct 24, 25 | K251784510(k) | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | Dental | LRK |
| Oct 24, 25 | K251827510(k) | Azurion R3.1 | Philips Medical Systems B.V. | Radiology | OWB |
| Oct 24, 25 | K251974510(k) | Arctic Sun Temperature Management System (Model 5000) | Medivance, Inc. | Cardiovascular | DWJ |
| Oct 24, 25 | K252044510(k) | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Orthopedic | MBH |
| Oct 24, 25 | K252238510(k) | CoroFlow Cardiovascular System | Coroventis Research AB | Cardiovascular | DQK |
| Oct 24, 25 | K252357510(k) | Glucose2 | Abbott Ireland | Clinical Chemistry | CFR |
| Oct 24, 25 | K252645510(k) | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Cardiovascular | DQK |
| Oct 24, 25 | K252646510(k) | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | Gastroenterology, Urology | FCG |
| Oct 24, 25 | K252730510(k) | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | Orthopedic | NKB |
| Oct 24, 25 | K253106510(k) | AngioVac Cannula | AngioDynamics, Inc. | Cardiovascular | DWF |
| Oct 24, 25 | K253125510(k) | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | General, Plastic Surgery | FTL |
| Oct 24, 25 | K253129510(k) | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKG |
| Oct 24, 25 | K253150510(k) | Cryon-X Cold Compression | Jkh Health Co., Ltd. | Physical Medicine | IRP |
| Oct 24, 25 | K253188510(k) | CoaguChek XS Plus System | Roche Diagnostics | Hematology | GJS |
| Oct 24, 25 | K253335510(k) | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | Orthopedic | NKB |
| Oct 24, 25 | K253377510(k) | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | Orthopedic | MAX |
| Oct 23, 25 | K250288510(k) | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | Radiology | QIH |
| Oct 23, 25 | K250861510(k) | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | General Hospital | LZA |
| Oct 23, 25 | K252309510(k) | PerQseal Introducers | Vivasure Medical Limited | Cardiovascular | DYB |
| Oct 23, 25 | K252345510(k) | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 23, 25 | K252384510(k) | DESS® Dental Smart Solutions | Terrats Medical SL | Dental | NHA |
| Oct 23, 25 | K252425510(k) | Silatrix Oral Gel | Sa3, LLC | Unknown | OLR |
| Oct 23, 25 | K252732510(k) | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | General, Plastic Surgery | GEX |
| Oct 23, 25 | K252931510(k) | Invisalign® Palatal Expander System | Align Technology, Inc. | Dental | NXC |
| Oct 23, 25 | K253100510(k) | MultiPulse TFL | Asclepion Laser Technologies GmbH | General, Plastic Surgery | GEX |
| Oct 23, 25 | K253226510(k) | UV5000W Handle | Uroviu Corporation | Gastroenterology, Urology | FAJ |
| Oct 22, 25 | K250666510(k) | Alegria Flash CTD Screen | Zeus Scientific | Immunology | LLL |
| Oct 22, 25 | K250955510(k) | XC11 ICE System, USA | Yorlabs, Inc. | Cardiovascular | OBJ |
| Oct 22, 25 | K251030510(k) | Sirona Advanced Imaging Suite | Sirona Medical | Radiology | LLZ |
| Oct 22, 25 | K251185510(k) | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene | Cardiovascular | QEW |
| Oct 22, 25 | K251289510(k) | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | Microbiology | QVF |
| Oct 22, 25 | K251628510(k) | Mandibular Advancement Device L07 | Dcstar, Inc. | Dental | LRK |
| Oct 22, 25 | K251663510(k) | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | General Hospital | FMZ |
| Oct 22, 25 | K251749510(k) | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | Microbiology | SCA |
| Oct 22, 25 | K251977510(k) | electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | Obstetrics/Gynecology | HGX |
| Oct 22, 25 | K252298510(k) | ANDI 2.0 | Imeka Solutions, Inc. | Radiology | QIH |
| Oct 22, 25 | K252322510(k) | SIros-X System | Genesys Spine | Orthopedic | OUR |
| Oct 22, 25 | K252325510(k) | Hair Growth Laser Cap | Cosmo Far East Technology Limited | Physical Medicine | OAP |
| Oct 22, 25 | K252329510(k) | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Microbiology | PCH |
| Oct 22, 25 | K252569510(k) | Carrier XL Delivery Catheter | Balt USA, LLC | Cardiovascular | QJP |
| Oct 22, 25 | K253144510(k) | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | Orthopedic | JWH |
| Oct 22, 25 | K253145510(k) | Pre-Sutured Tendon | Rti Surgical, Inc. | General, Plastic Surgery | GAT |
| Oct 22, 25 | K253147510(k) | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | Orthopedic | MQV |
| Oct 21, 25 | K231897510(k) | NeuroAlign software | Medivis, Inc. | Neurology | HAW |
| Oct 21, 25 | K250126510(k) | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Livsmed, Inc. | General, Plastic Surgery | GEI |
| Oct 21, 25 | K250394510(k) | Fine TTO | Bodycad Laboratories, Inc. | Orthopedic | PBF |
| Oct 21, 25 | K250409510(k) | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | Gastroenterology, Urology | FGE |
| Oct 21, 25 | K250887510(k) | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | Anesthesiology | KOI |
| Oct 21, 25 | K251838510(k) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Cardiovascular | DYB |
| Oct 21, 25 | K252346510(k) | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | Orthopedic | NKB |
| Oct 21, 25 | K253033510(k) | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | General Hospital | ONB |
| Oct 21, 25 | K253034510(k) | HemoSphere Stream Module | Edwards Lifesciences | Cardiovascular | DQK |
| Oct 21, 25 | K253040510(k) | Aevumed FASE Suture Anchor | Aevumed, Inc. | Orthopedic | MBI |
| Oct 21, 25 | K253249510(k) | TriALTIS Spine System | Medos International SARL | Orthopedic | NKB |
October 2026
September 2026
August 2026
July 2026
June 2026
May 2026
April 2026
March 2026
February 2026
January 2026
December 2025
November 2025
October 2025
Source: FDA 510(k) and PMA databases via openFDA. PMA supplements are excluded.