The Tracker // 510(k) · PMA · by month

Every FDA device decision, last 12 months

3,299 decisions on file: 3,252 510(k) clearances and 47 original PMA approvals. Rows link to a page per decision with panel, product code, regulation, review time and the FDA summary. Applicants in the startup directory are linked.

NOTABLE

EDITOR-FLAGGED DECISIONS

Decision	Number	Device	Applicant	Panel	Code
Oct 11, 26	K253717510(k)	Helo Return	Endovascular Engineering, Inc.	Anesthesiology	CAC
Oct 6, 26	K261141510(k)	OpenFlo Urinary Catheter	Urolution Medical, Inc.	Gastroenterology, Urology	EZL
Oct 6, 26	K262798510(k)	LOBO Vascular Occlusion System	Okami Medical, Inc.	Cardiovascular	KRD
Oct 5, 26	K260005510(k)	MyoVista wavECG (DG-200-B15-003)	HeartSciences, Inc.	Cardiovascular	DPS
Oct 2, 26	K260064510(k)	Neurora	Argus Cognitive, Inc.	Neurology	QPF
Oct 2, 26	K260490510(k)	Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)	Shenzhen Ninenovo Technology Limited	Cardiovascular	DQA
Oct 1, 26	K261612510(k)	SwiftSight-BodyComposition	Airs Medical, Inc.	Radiology	LNH
Sep 29, 26	DEN260007510(k)	SmartRead(TM) Medical Device Identifier (4100)	BridgeSource Medical Corporation	Cardiovascular	SJJ
Sep 29, 26	K262015510(k)	Elucid FFR-IQ (B.1)	Elucid Bioimaging, Inc.	Cardiovascular	PJA
Sep 25, 26	K254255510(k)	S-Patch CardioAI	Wellysis Corp.	Cardiovascular	DPS
Sep 25, 26	K260023510(k)	TumorSight Risk	SimBioSys, Inc.	Pathology	SHW
Sep 25, 26	K260140510(k)	Aevice Wheeze Detection Module	Aevice Health Pte. , Ltd.	Anesthesiology	PHZ
Sep 24, 26	K262149510(k)	corra® cervical plating system	Carlsmed, Inc.	Orthopedic	KWQ
Sep 21, 26	K253509510(k)	TriSalus TriNav Advance Infusion System	Trisalus Life Sciences	Cardiovascular	KRA
Sep 18, 26	K261855510(k)	Elucid PlaqueIQ	Elucid Bioimaging, Inc.	Radiology	LLZ
Sep 18, 26	K262262510(k)	Pathfinder Endoscope Overtube	Neptune Medical, Inc.	Gastroenterology, Urology	FED
Sep 18, 26	K262599510(k)	Biolinq Shine Autonomous Time-in-Range Microsensor	Biolinq Incorporated	Clinical Chemistry	SFU
Sep 18, 26	K262817510(k)	CrossFAST Integrated Microcatheter Advanced Delivery System	Vantis Vascular, Inc.	Cardiovascular	DQY
Sep 17, 26	K260677510(k)	Vessel Closure Device (VCD177213P)	Vcd Medical S.R.L.	General, Plastic Surgery	FZP
Sep 16, 26	K260220510(k)	Route 92 Medical Full Length 046 Access System	Route 92 Medical, Inc.	Cardiovascular	QJP
Sep 16, 26	K261712510(k)	Ceribell EEG Analysis Software	Ceribell, Inc.	Neurology	OLT
Sep 16, 26	K261913510(k)	X°Port Heart Preservation System	Traferox Technologies, Inc.	Gastroenterology, Urology	MSB
Sep 14, 26	K262193510(k)	RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology	Xenix Medical	Orthopedic	NKB
Sep 11, 26	K260001510(k)	Mint ACE Pump	Beta Bionics, Inc.	Clinical Chemistry	QFG
Sep 11, 26	K261305510(k)	MICSI-PET	Microstructure Imaging, Inc.	Radiology	KPS

THIS MONTH: OCTOBER 2026

87 DECISIONS

Decision	Number	Device	Applicant	Panel	Code
Oct 11, 26	K253717510(k)	Helo Return	Endovascular Engineering, Inc.	Anesthesiology	CAC
Oct 9, 26	K260080510(k)	Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler	Medical Components, Inc.	General Hospital	LJS
Oct 9, 26	K260096510(k)	Wishbone HAE	Wishbone SA	Dental	NPM
Oct 9, 26	K260156510(k)	TruVision Single-Use 1.9mm Arthroscopy System	Nexus CMF, LLC	Orthopedic	HRX
Oct 9, 26	K260687510(k)	VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.	Vivachek Biotech (Hangzhou) Co., Ltd.	Clinical Chemistry	NBW
Oct 9, 26	K260913510(k)	CMF Titanium Splints	Materialise NV	Dental	DZJ
Oct 9, 26	K261234510(k)	The D-Tip Denudation Pipette	Allwin Medical Devices, Inc.	Obstetrics/Gynecology	MQH
Oct 9, 26	K261521510(k)	Sleep Analysis Module	Neurotronics, LLC	Neurology	OLZ
Oct 9, 26	K261649510(k)	Excelsior Reach Microcatheter	Stryker Neurovascular	Cardiovascular	QJP
Oct 9, 26	K262068510(k)	Khelix Magnetic Sensor Electrophysiology Catheter (SS1---MAG)	CathRx, Ltd.	Cardiovascular	DRF
Oct 9, 26	K262090510(k)	Fertilis microICSI Device	Fertilis Pty, Ltd.	Obstetrics/Gynecology	MQK
Oct 9, 26	K262301510(k)	Rapid ICH (v4.0)	Ischemaview, Inc.	Radiology	QAS
Oct 9, 26	K262352510(k)	IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	General, Plastic Surgery	OHT
Oct 9, 26	K262834510(k)	Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	Physical Medicine	OAP
Oct 9, 26	K262902510(k)	ECHELON Synergy	Fujifilm Corporation	Radiology	LNH
Oct 9, 26	K263154510(k)	CarboClear® Cervical Navigated Instruments	CarboFix Orhtopedics , Ltd.	Neurology	OLO
Oct 8, 26	K260426510(k)	MeCare Alpha (MCA2019)	IVT Medical, Ltd.	General, Plastic Surgery	OMP
Oct 8, 26	K261617510(k)	Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic Ultrasoun	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	Radiology	IYN
Oct 8, 26	K261805510(k)	NEXT-Cue	Neuroxt, Inc.	Neurology	QWT
Oct 8, 26	K262244510(k)	Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328)	Stryker Instruments	Unknown	LFL
Oct 8, 26	K262346510(k)	CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)	Wuhan Phomed Technology Co., Ltd.	General, Plastic Surgery	GEX
Oct 8, 26	K263150510(k)	V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	Radiology	IYN
Oct 8, 26	K263680510(k)	One Coat Bond; One Coat Bond SL	Dent4You AG	Dental	KLE
Oct 7, 26	K260075510(k)	eClinics	Ceiba Healthcare US, Inc.	Cardiovascular	MSX
Oct 7, 26	K260092510(k)	Vista AI Scan	Vista AI, Inc.	Radiology	LNH
Oct 7, 26	K261120510(k)	APEX 3D S Diamond Tibia	Paragon 28, Inc.	Orthopedic	HSN
Oct 7, 26	K261692510(k)	Diode Laser Hair Removal Machine (QDTM-03)	Beijing Nubway S&T Co., Ltd.	General, Plastic Surgery	GEX
Oct 7, 26	K261733510(k)	Ligence Heart	UAB Ligence	Radiology	QIH
Oct 7, 26	K262134510(k)	NeuroDR	Deep Reasoning Ai, Inc.	Radiology	QIH
Oct 7, 26	K262368510(k)	B. anthracis Real-time PCR Assay	Centers for Disease Control and Prevention	Microbiology	NHT
Oct 7, 26	K262378510(k)	Dr.AlignNavi	InnoDtech, Inc.	Dental	PNN
Oct 7, 26	K262822510(k)	Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)	Zhongshan GL Electronics Co. , Ltd.	General, Plastic Surgery	BTA
Oct 7, 26	K263159510(k)	prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments	Centinel Spine, LLC	Orthopedic	QLQ
Oct 6, 26	K260136510(k)	Forza	True Function Laboratory, Inc.	Dental	LRK
Oct 6, 26	K261079510(k)	Power Wheelchair (DC12)	Anhui JBH Medical Apparatus Co., Ltd.	Physical Medicine	ITI
Oct 6, 26	K261141510(k)	OpenFlo Urinary Catheter	Urolution Medical, Inc.	Gastroenterology, Urology	EZL
Oct 6, 26	K261200510(k)	Power Wheelchair (D60)	Anhui JBH Medical Apparatus Co., Ltd.	Physical Medicine	ITI
Oct 6, 26	K261887510(k)	Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT)	NormaTec Industries, LP	Physical Medicine	IRP
Oct 6, 26	K261938510(k)	APRO 88 Catheter	Alembic, LLC	Cardiovascular	QJP
Oct 6, 26	K262043510(k)	MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike	Bayer Medical Care, Inc.	Cardiovascular	DXT
Oct 6, 26	K262516510(k)	TSK OptiXion	Tsk Laboratory, Japan	General Hospital	QYM
Oct 6, 26	K262798510(k)	LOBO Vascular Occlusion System	Okami Medical, Inc.	Cardiovascular	KRD
Oct 5, 26	K260005510(k)	MyoVista wavECG (DG-200-B15-003)	HeartSciences, Inc.	Cardiovascular	DPS
Oct 5, 26	K260523510(k)	QGuideCT (1.0)	Medis Medical Imaging Systems BV	Radiology	QIH
Oct 5, 26	K261655510(k)	RT Elements (4.6)	Brainlab SE	Radiology	MUJ
Oct 5, 26	K261939510(k)	Glucommander	Glytec, LLC	Anesthesiology	NDC
Oct 5, 26	K262285510(k)	UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)	Shijiazhuang Recovery Star Medical Device Co., Ltd.	General, Plastic Surgery	FTC
Oct 5, 26	K262812510(k)	Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)	Sichuan Qianli-Beoka Medical Technology, Inc.	Physical Medicine	IRP
Oct 5, 26	K262813510(k)	InkSpace Imaging Small Body Array (SBA12PH15x)	Inkspace Imaging, Inc.	Radiology	MOS
Oct 2, 26	K253422510(k)	OAB Delivery Catheter	Cognition Medical Corp.	Cardiovascular	QJP
Oct 2, 26	K254030510(k)	cCeLL405	VPIX Medical, Inc.	Neurology	QFX
Oct 2, 26	K260044510(k)	Ventricular Catheters, Thomale Catheter	Aesculap, Inc.	Neurology	JXG
Oct 2, 26	K260064510(k)	Neurora	Argus Cognitive, Inc.	Neurology	QPF
Oct 2, 26	K260221510(k)	Elecsys EBV EBNA IgG	Roche Diagnostics	Microbiology	LSE
Oct 2, 26	K260232510(k)	Elecsys EBV VCA IgG	Roche Diagnostics	Microbiology	LSE
Oct 2, 26	K260233510(k)	Elecsys EBV IgM	Roche Diagnostics	Microbiology	LJN
Oct 2, 26	K260468510(k)	H100Plus Hemoglobin Testing System	Shenzhen Lifotronic Technology Co., Ltd.	Clinical Chemistry	PDJ
Oct 2, 26	K260487510(k)	stentFIX System Set (100.50n)	Ovesco Endoscopy AG	Gastroenterology, Urology	PKL
Oct 2, 26	K260490510(k)	Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)	Shenzhen Ninenovo Technology Limited	Cardiovascular	DQA
Oct 2, 26	K260689510(k)	CVS Advanced PLUS Blood Glucose Monitoring System	I-Sens, Inc.	Clinical Chemistry	NBW
Oct 2, 26	K261042510(k)	Lung Guidance	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	Radiology	QJU
Oct 2, 26	K261217510(k)	AnyPlus II Spinal Fixation System	GS Medical Co., Ltd.	Orthopedic	NKB
Oct 2, 26	K261607510(k)	Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System	Spinal Simplicity, LLC	Orthopedic	PEK
Oct 2, 26	K261611510(k)	TDM Large Bone Plate and Screw System	Tdm Co., Ltd.	Orthopedic	HRS
Oct 2, 26	K261741510(k)	Hemostatic Clip	Anrei Medical (Hz) Co., Ltd.	Gastroenterology, Urology	PKL
Oct 2, 26	K261783510(k)	Plenity-V (MC0979 / GS110)	Gelesis SRL	Gastroenterology, Urology	QFQ
Oct 2, 26	K261791510(k)	MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor	Steris	Gastroenterology, Urology	FEB
Oct 2, 26	K261933510(k)	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	Radiology	IYN
Oct 2, 26	K261943510(k)	REMEX-T(K)100C	Remedi, Inc.	Radiology	IZL
Oct 2, 26	K262412510(k)	Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)	Barco NV	Radiology	PGY
Oct 2, 26	K262985510(k)	Medical Monitor (32MD08WC)	Lg Electronics.Inc	Radiology	PGY
Oct 2, 26	K263083510(k)	Response Ortho Smart Fixator - Hexapod System	Response Ortho Solutions, LLC	Orthopedic	KTT
Oct 2, 26	K263086510(k)	AltiVate Reverse® Glenosphere with RAVN Technology	Encore Medical L.P.	Orthopedic	PHX
Oct 2, 26	K263113510(k)	ZSAlign Cervical Interbody System	ZSFab, Inc.	Orthopedic	OVE
Oct 2, 26	K263116510(k)	OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts	OsteoCentric Technologies	Orthopedic	HWC
Oct 2, 26	K263120510(k)	Xpert Xpress CoV-2/Flu plus	Cepheid®	Microbiology	QOF
Oct 1, 26	K260027510(k)	Firstar Dental Electric Motor	FDC Technology Industry Co.	Dental	EBW
Oct 1, 26	K260029510(k)	Firstar Dental Handpieces	FDC Technology Industry Co.	Dental	EFB
Oct 1, 26	K260283510(k)	VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)	bioMerieux, Inc.	Microbiology	LON
Oct 1, 26	K260470510(k)	Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)	Shenzhen Brav Electronic Technologies Co., Ltd.	Cardiovascular	DXN
Oct 1, 26	K261612510(k)	SwiftSight-BodyComposition	Airs Medical, Inc.	Radiology	LNH
Oct 1, 26	K262208510(k)	Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink	Yty Industry (Manjung) Sdn Bhd	General Hospital	LZA
Oct 1, 26	K262473510(k)	NEXUS® Hip Stem	Microport Orthopedics, Inc.	Orthopedic	LZO
Oct 1, 26	K263016510(k)	Intra-Operative Positioning System (IOPS) and IOPS Visionary System	Centerline Biomedical	Cardiovascular	DQK
Oct 1, 26	K263062510(k)	NOVIX Pedicle Screw System	Tdm Co., Ltd.	Orthopedic	NKB
Oct 1, 26	K263092510(k)	Dual Stage Venous Cannulae	Sorin Group Italia S.R.L.	Cardiovascular	DWF
Oct 1, 26	P260007PMA	Autus Size-Adjustable Valve	Edwards Lifesciences, LLC	Cardiovascular	SJL

Source: FDA 510(k) Premarket Notification and PMA databases via openFDA. Decision dates are FDA decision dates. PMA supplements are excluded. Data refreshes on every site rebuild; FDA posts decisions weekly, so the newest week is always partial.