510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | ESW | Class II | |
| K003017 | Gramsorb Synthetic Absorbable Suture | Gramsmed, LLC | GAM | Class II | |
| K002862 | Proneb Ultra Model Number 85B0100 | Pari Holding Co. | BTI | Class II | |
| K002153 | Ultrasonic Nebulizer, Model Ne-520 | Medisana USA Corp. | CAF | Class II | |
| K001354 | Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System | Biomedical Ent., Inc. | JDR | Class II | |
| K001353 | Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System | Biomedical Ent., Inc. | HBW | Class II | |
| K010572 | Bd Visidrape Ophthalmic Drapes; Bd Visiflex Incise Drape | Becton Dickinson & Co | KKX | Class II | |
| K010548 | Modification to Optical Tracking System (Ots) | Radionics, A Division of Tyco Healthcare Group LP | HAW | Class II | |
| K010435 | Philips Bv Pulsera/endura | Philips North America LLC | OWB | Class II | |
| K010393 | Apollo Mobile C Arm System | Cares Built, Inc. | OXO | Class II | |
| K010392 | Athena Remote Controlled RF System | Cares Built, Inc. | JAA | Class II | |
| K010391 | Atlas Multi-Purpose Dsa System | Cares Built, Inc. | IZI | Class II | |
| K010165 | Ero Scan Oae Test System | Etymotic Research, Inc. | EWO | Class II | |
| K010126 | Prosthetic, Gelflex Alpha, (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted) | Cl-Tinters | LPL | Class II | |
| K010082 | D.o.r.c. Harmony Total Ttc Vitrectomy System | Dutch Ophthalmic USA, Inc. | HQE | Class II | |
| K003837 | Flexiview 8800 Digital Mobile Imaging System | GE Healthcare | OXO | Class II | |
| K010521 | Nicolet Versalab | Nicolet Biomedical, Inc. | JAF | Class II | |
| K010505 | Telemed 12 Lead Resting ECG Analysis Library | Brentwood Medical Technology Corp. | DPS | Class II | |
| K010495 | Centura Phototherapy Spotlight | Medical Illumination International, Inc | LBI | Class II | |
| K010390 | Acist Angiographic Injection System, Model R2000-Cms | Acist Medical Systems, Inc. | DXT | Class II | |
| K010367 | Modification to Titanium Tri-Lock Hips Stem | Depuy Orthopaedics Inc. | LPH | Class II | |
| K010182 | Vcf Personal Lubricant | Apothecus Pharmaceutical Corp. | NUC | Class II | |
| K010040 | Sleeved Filter | King Systems Corporation. | CAH | Class II | |
| K003867 | Exam Room Astroglide (Professional Market), Target Lubricating Jelly (OTC Consumer Market) | Biofilm, Inc. | NUC | Class II | |
| K003816 | Arthrex Titanium Corkscrew, 3.5 Mm, Arthrex Titanium Corkscrew, 5.0 Mm, Arthrex Titanium Corkscrew 6.5Mm | Arthrex GmbH | HWC | Class II | |
| K003594 | Carriazo Barraquer Single Use Microkeratome | Moria SA | HMY | Class I | |
| K003299 | Opd-Scan, Models Ark-10000 and Ark-9000 | Nidek, Inc. | HLQ | Class I | |
| K002150 | Sonicaid Fm820, Sonicaid Fm830 | Oxford Instruments, PLC. | HGM | Class II | |
| K010442 | Kurz Angular Piston-Titanium Prosthesis, Models 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 | Heinz Kurz | ETB | Class II | |
| K010426 | Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone Catheter | Sims Deltec, Inc. | LJT | Class II | |
| K010416 | Heraceram 75 | Jelenko Co. | EJT | Class II | |
| K004034 | Monitect Multiple Drug Screen Tests, Model Bc12,bc14,tc10,pc11, and Pc12 | Branan Medical Corp. | DKZ | Class II | |
| K003908 | Serojet | Bioject, Inc. | KZE | Class II | |
| K003861 | Benz-Mf (Visibility Hangling Tint) (Methafilcon a) Soft Daily Wear Contact Lens (Lathe-Cut) | Benz Research and Development LLC | LPL | Class II | |
| K003826 | Focus Dailies Progressives | Alcon Laboratories | MVN | Class II | |
| K003824 | Omnisonics Ultrasonic Surgery System, Model Sti | Omnisonics Medical Technologies | LFL | Unclassified | |
| K003820 | Disposable Cb-Pe Microkeratome Blades | Oasis Medical, Inc. | HNO | Class I | |
| K003787 | Newtom Qr-Dvt 9000 | Aperio Services, LLC | OAS | Class II | |
| K003369 | Lifecare Compact TENS Device | Lifecare, Ltd. | GZJ | Class II | |
| K003058 | Laser 3 Spsc300 | Pride Mobility Products Corp | INI | Class II | |
| K002907 | Pvs 1300 Neuro Guide Wire | Precision Vascular Systems, Inc. | DQX | Class II | |
| K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | MSB | Class II | |
| K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics GmbH | LFR | Class II | |
| K010339 | Endocare Percutaneous Access Set | Varian Medical Systems, Inc. | KOD | Class II | |
| K010338 | Artic Sun Temperature Management System, Model 200 | Medivance Inc. | DWJ | Class II | |
| K010289 | Scimedx Phase II Mpo Igg Antibody Eia | Scimedx Corp. | MOB | Class II | |
| K010041 | Slt Diffuser Fiber | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K003998 | Flexview Clinical Monitoring System | Data Critical Corp. | MSX | Class II | |
| K003803 | General Surgical Laparoscopes | Global Endoscopy, Inc. | GCJ | Class II | |
| K003758 | Allofit Acetabular System | Sulzer Orthopedics, Inc. | KWA | Class III |