The FDA decisions that matter to founders, backed by a tracker of every 510(k) clearance and original PMA approval from the last 12 months.
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Aug 16, 26 | K260563510(k) | CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | Neurology | OLX |
| Aug 14, 26 | K253562510(k) | medilogFD | Schiller AG | Cardiovascular | MWJ |
| Aug 14, 26 | K253747510(k) | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | General Hospital | FMF |
| Aug 14, 26 | K260171510(k) | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | Anesthesiology | CAW |
| Aug 14, 26 | K260374510(k) | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | Neurology | GYD |
| Aug 14, 26 | K260438510(k) | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | Cardiovascular | MWI |
| Aug 14, 26 | K260559510(k) | NHanceIT | IMDS Operation B.V. | Cardiovascular | DQY |
| Aug 14, 26 | K260898510(k) | Transpara (2.1.0) | Screenpoint Medical B.V. | Radiology | QDQ |
| Aug 14, 26 | K261228510(k) | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | Neurology | OBP |
| Aug 14, 26 | K261428510(k) | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | Cardiovascular | LOX |
| Aug 14, 26 | K261646510(k) | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | Unknown | FRO |
| Aug 14, 26 | K261890510(k) | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | Gastroenterology, Urology | KNT |
| Aug 14, 26 | K262419510(k) | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. | Neurology | HCG |
| Aug 14, 26 | K262424510(k) | Willow 12 Guidewire | Arbor Endovascular, LLC | Cardiovascular | MOF |
| Aug 14, 26 | K262449510(k) | AdvaView | ADVAHEALTH SOLUTIONS, LLC | Radiology | LLZ |
| Aug 14, 26 | K262452510(k) | AutoContour (RADAC V6) | Radformation, Inc. | Radiology | QKB |
| Aug 14, 26 | K262552510(k) | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | Gastroenterology, Urology | FGB |
| Aug 14, 26 | K262571510(k) | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Gastroenterology, Urology | KNW |
| Aug 14, 26 | K262639510(k) | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | Orthopedic | QLQ |
| Aug 13, 26 | K253425510(k) | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | Cardiovascular | DXN |
| Aug 13, 26 | K253790510(k) | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | Physical Medicine | NGX |
| Aug 13, 26 | K253795510(k) | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | Ophthalmic | LPN |
| Aug 13, 26 | K253808510(k) | AIR Recon DL | GE Medical Systems | Radiology | LNH |
| Aug 13, 26 | K254201510(k) | Any-Cem | Mediclus Co., Ltd. | Dental | EMA |
| Aug 13, 26 | K260211510(k) | Dashboard (P007000) | Hill-Rom, Inc. | Cardiovascular | MSX |
| Aug 13, 26 | K260277510(k) | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | Orthopedic | HRS |
| Aug 13, 26 | K260413510(k) | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | Ear, Nose, Throat | KLW |
| Aug 13, 26 | K260907510(k) | BIS Advance pEEG Module | Covidien LP | Neurology | OLW |
| Aug 13, 26 | K261061510(k) | BP Go (BPP-855) | Wellvii, Inc. | Cardiovascular | DXN |
| Aug 13, 26 | K261139510(k) | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | Gastroenterology, Urology | GCJ |
| Aug 13, 26 | K261499510(k) | TrachFlush | Aw Technologies Aps | Anesthesiology | BSK |
| Aug 13, 26 | K261626510(k) | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | Dental | EBI |
| Aug 13, 26 | K262398510(k) | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | CERENOVUS, Inc. | Cardiovascular | NRY |
| Aug 12, 26 | K251641510(k) | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | Anesthesiology | CCK |
| Aug 12, 26 | K253417510(k) | Masimo Root Monitoring System | Masimo Corporation | Cardiovascular | MWI |
| Aug 12, 26 | K253846510(k) | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. | General, Plastic Surgery | OAB |
| Aug 12, 26 | K260086510(k) | CadAI-B Dx | BeamWorks, Inc. | Radiology | QDQ |
| Aug 12, 26 | K260944510(k) | ManaCold Compression System | Manamed, LLC | Physical Medicine | IRP |
| Aug 12, 26 | K261170510(k) | BA-004CC | Fujifilm Corporation | Radiology | ITX |
| Aug 12, 26 | K261916510(k) | NeuroQuant PET | Cortechs Labs, Inc. | Radiology | LLZ |
FDA granted De Novo authorization to Vitestro's Aletta on August 19, 2026, the first device that performs a venous blood draw with no hands-on operator. The Utrecht company raised a $70M Series B in March, led by Labcorp Venture Fund, Mayo Clinic and Sutter Health.
FDA cleared Jupiter Endovascular's Vertex Thrombectomy System (K261523) on August 4, 2026, for removing emboli and thrombi from the pulmonary arteries. The Menlo Park startup filed the traditional 510(k) on May 7, two weeks before presenting its 123-patient SPIRARE II results at EuroPCR.
FDA cleared Wandercraft's Eve exoskeleton (K260381) on August 3, 2026, for adults with spinal cord injury at any level to walk hands-free at home. The Paris company, which raised a $75M Series D in June 2025 with Renault Group and Bpifrance, plans a U.S. launch on September 17.
FDA granted Caristo Diagnostics a De Novo (DEN250042) for CaRi-Heart on July 28, 2026, creating a new class of predictive indicator for long-term cardiovascular outcomes. The Oxford spinout's software quantifies coronary inflammation from routine coronary CT angiography and reports a 10-year cardiac mortality risk.
FDA granted premarket approval to Freenome's SimpleScreen CRC (P250029) on July 24, 2026, a blood-based colorectal cancer screen for average-risk adults 45 and older. The approval earns Freenome a $100M milestone from Abbott, which holds exclusive U.S. commercial rights, three days after the company began trading on Nasdaq.
FDA approved Traferox's TorEx Lung Perfusion System (P250025) on July 15, 2026, for ex vivo perfusion of donor lungs initially judged unsuitable for transplant. The Mississauga company was founded in 2021 as a spinout of University Health Network's Toronto General Hospital.
FDA granted Claria Medical a De Novo (DEN250034) on July 2, 2026, for the Claria System, a contained tissue removal device for hysterectomy. The grant-funded Mountain View company reported a median four-minute extraction time for large uteri in its multinational controlled study.
FDA approved HepQuant's SHUNT Liver Diagnostic Test (P220016) on June 18, 2026, to flag compensated cirrhosis patients who can skip a varices screening endoscopy. FDA received the Colorado company's application on September 14, 2022, a 1,373-day review.
FDA approved CyndRx's AbsorbaSeal 5.6.7F Vascular Closure Device (P230038) on June 5, 2026, for femoral arterial access sites after procedures using 5F to 7F sheaths. The Brentwood, Tennessee company filed the PMA in November 2023 on the strength of the 220-patient SEAL TO HEAL IDE trial.
FDA granted Cardiosense a De Novo (DEN250057) on May 22, 2026, for software that estimates wedge pressure from its chest-worn CardioTag sensor in HFrEF patients. The Chicago company cleared the sensor itself under a 510(k) in July 2025.
FDA approved Endospan's NEXUS Aortic Arch Stent Graft System (P250033) on April 2, 2026, for chronic dissections involving the aortic arch in high-risk surgical patients. Artivion, which distributes NEXUS in Europe, now has 90 days to exercise an option to buy the 50-person Israeli company.
FDA approved JenaValve Technology's Trilogy Transcatheter Heart Valve System (P250024) on March 17, 2026, for symptomatic, severe aortic regurgitation in patients at high surgical risk. The decision came two months after a federal judge blocked Edwards Lifesciences' $1.2B bid for the Irvine company.
FDA cleared Perfuze's Millipede System (K253590) on March 16, 2026, making the 0.088-inch Millipede88 the first super-bore catheter indicated for standalone direct aspiration in stroke. The Galway company backed the filing with the 180-patient MARRS study and had raised €22M from existing investors a year earlier.
FDA approved Perimeter Medical Imaging AI's Claire OCT System (P250008) on March 3, 2026, for margin assessment of excised lumpectomy tissue during surgery. The Toronto company, listed on the TSX Venture Exchange, reported 88.1% margin accuracy in a trial funded by a $7.4M CPRIT grant.
FDA approved the Synergy Disc on February 26, 2026 under P250028, 210 days after Synergy Spine Solutions filed the PMA. The Louisville, Colorado company's single-level cervical disc beat ACDF fusion on composite clinical success, 87.1% with p<0.0001, in its IDE trial.
FDA approved the Allurion Gastric Balloon System on February 20, 2026 under P250023. The label covers adults 22 to 65 with a BMI of 30 to 40. In the 550-patient AUDACITY trial the responder co-primary endpoint passed while the comparative endpoint missed its 3% superiority margin.
FDA approved Empirical Spine's LimiFlex Dynamic Sagittal Tether on February 12, 2026 under P220031, a PMA received December 19, 2022. The motion-preserving alternative to fusion for Grade I degenerative spondylolisthesis held Breakthrough designation since April 2021 and was tested against 160 TLIF patients.
FDA approved Neurolief's ProlivRx headset on December 31, 2025 under P250010. The label is adjunctive at-home treatment for major depressive disorder in adults who failed at least one antidepressant. The approval trips a milestone in BrainsWay's August 2025 deal, which committed up to $6 million more on FDA approval.
FDA granted HAI Solutions' De Novo request for the QIKCAP System on December 23, 2025. The grant creates a new Class II regulation, 21 CFR 880.6512, for UVC microbial reduction devices for luer-activated valves. The Carlsbad startup announced DEN250004 on December 30 after a 327-day review.
FDA cleared UpDoc on December 23, 2025 under K253281, 85 days after the Mountain View startup filed. The prescription software takes glucose, meal and symptom data through a voice or chat agent and issues insulin instructions from prescriber-set parameters. The 510(k) summary reports no clinical testing.
FDA approved Zenflow's Spring Implant and Delivery System for BPH on December 11, 2025 under P250007, a 275-day review. In the BREEZE trial of more than 200 men, 60% of treated patients were responders at one year versus 33% on sham.
FDA approved Flow Neuroscience's FL-100 tDCS headset on December 8, 2025 under P230024. It is the first prescription at-home brain stimulation device for major depressive disorder in the US. The Malmö startup filed in August 2023 and backed the PMA with a 174-patient sham-controlled trial.
FDA approved ProVerum's ProVee System for BPH on December 9, 2025 under P250011, a 251-day review. The Dublin company closed an $80 million Series B led by MVM Partners on August 25 to fund the US launch.
FDA approved Cleveland Diagnostics' IsoPSA blood test on November 28, 2025 under P200048, a PMA the agency received on December 28, 2020. The test is indicated for men 50 and older with PSA between 4.0 and 10.0 ng/mL who are being considered for biopsy.
FDA granted Pulsenmore's De Novo request for the Pulsenmore ES home prenatal ultrasound on October 31, 2025, creating a new device type under DEN240074. The Israeli company's shares rose 33% on the Tel Aviv Stock Exchange when it announced the grant on November 3.
FDA cleared Bunkerhill MAC on October 3, 2025 under K250662. It is the first AI algorithm cleared to detect and quantify mitral annular calcification on routine non-gated chest CT. It is the San Francisco company's seventh 510(k) since April 2023 and its second in 14 days.
FDA cleared Jupiter Endovascular's Vertex catheter on September 12, 2025 under K252027, 74 days after the June 30 submission. The clearance covers insertion of endovascular devices; the pulmonary embolism claim still depends on the SPIRARE II trial.
FDA approved Womed's Leaf resorbable adhesion barrier on September 9, 2025 under P240015, the first US device for moderate to severe intrauterine adhesions. The Montpellier startup filed in May 2024 and backed the PMA with a 160-patient trial.
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