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 |
|---|---|---|---|---|---|
| K012109 | Dri Ecstasy Urine Calibrators | Microgenics Corporation | DLJ | Class II | |
| K011972 | Direct Bilirubin Reagent | Intersect Systems, Inc. | CIG | Class II | |
| K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound Ctr, Eus Exera Ultrasonic Gastrovideoscope Olympus Gf Type Um 160, | OLYMPUS Corporation of the Americas | ODG | Class II | |
| K011715 | Macropore Ib Resorbable Plug | Macropore Biosurgery, Inc. | JDI | Class II | |
| K011661 | Concord 88 | Gateway Alloys, Inc. | EJT | Class II | |
| K011659 | Gpw-Sf | Gateway Alloys, Inc. | EJT | Class II | |
| K011657 | Hdr Tandem/ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K011646 | Neuroedge Infusion Catheter | Neuro Vasx, Inc. | KRA | Class II | |
| K010411 | Palmaz Genesis Transhepatic Billary Stent and Delivery System | Cordis US Corp. | FGE | Class II | |
| K002328 | Sios-Interface for Auto Light Projector, Sios-Interface for 3 Ccd Endocam, Sios-Interface for Laparo CO2 Insufflator | Richard Wolf Medical Instruments Corp. | HIF | Class II | |
| K012445 | Ems Swiss Lithoclast Master (A.k.a. Swiss Lithoclast Ultra) | E.M.S. - Electro Medical Systems SA | FFK | Class II | |
| K012399 | Modification to Elecsys Fsh II Calset | Roche Diagnostics GmbH | JIT | Class II | |
| K012365 | Vaxcel Dialysis Catheter | Boston Scientific Corporation | MSD | Class II | |
| K012319 | Randox Human Asssayed Drug Control | Randox Laboratories, Limited | DIF | Class I | |
| K012252 | Quik-Check Ovulation Predictor | Acon Laboratories, Inc. | CEP | Class I | |
| K012196 | Ultracell Absorbent Stick | Ultracell Medical Technologies, Inc. | HOZ | Class II | |
| K012161 | Flex-Nails | Fixano SA | HTY | Class II | |
| K012096 | Disposable Vitrectomy Lens | Ocular Instruments, Inc. | HJK | Class II | |
| K011946 | The Spin Snap-Off Screw | New Deal, S.A. | HWC | Class II | |
| K011746 | Mb 11 | Maico Diagnostic GmbH | GWJ | Class II | |
| K011744 | Hp-5, Battery Operated, Rear Wheel Drive, Power Wheelchair | Transworld Mobility Distribution, LLC | ITI | Class II | |
| K011072 | Gelflex Triton Hw Soft Bifocal Contact Lens and the Gelflex Triton Soft Bifocal Contact Lens | Gelflex | LPL | Class II | |
| K011025 | Fortaflex Surgical Mesh | Organogenesis, Inc. | FTM | Class II | |
| K003924 | Mavidon Medical Electrode Jelly | Mavidon Medical Products | GYB | Class II | |
| K002339 | Aems V, Ems-1000, Model Ts-140500 and Aems VI, Ems-1000 Plus, Model Ts-140600 | Apex Medical, Inc. | IPF | Class II | |
| K012567 | Modification to: Reaads Anti-Phosphatidylserine Igg/igm Semi-Quantitative Test Kit | Corgenix, Inc. | MID | Class II | |
| K012560 | Ge Logiq A100 Mp, Model 2272413 | General Electric Co. | IYO | Class II | |
| K012538 | Tubing and Connectors with Trillium Biopassive Surface | Medtronic, Inc. | DWF | Class II | |
| K012374 | Modification to: Lofric Plus Single Use Urinary Catheter | Astra Tech, Inc. | GBM | Class II | |
| K012362 | Modification to Vascular Closure Device | Std Mfg., Inc. | GDW | Class II | |
| K012347 | Protege Self-Expanding Nitinol Stent with Starport Delivery Technology | Sulzer Intratherapeutics, Inc. | FGE | Class II | |
| K012316 | Permacem / Permacem Dual | Dmg USA, Inc. | EMA | Class II | |
| K012307 | Luxacore/luxacore Dual | Dmg USA, Inc. | EBF | Class II | |
| K012231 | Avante Micro Crystal System | Jeneric/Pentron, Inc. | EIH | Class II | |
| K011762 | Hi-Wave; Pour-Plus | Denplus, Inc. | EBI | Class II | |
| K011759 | Radius Next Generation Guidewire | Radius Medical Technologies, Inc. | OCY | Class II | |
| K011698 | Straumann Gbr System | Straumann USA, LLC | JEY | Class II | |
| K010918 | Lifepak 12 Defibrillator/monitor System | Physio Control, Inc. | MKJ | Class III | |
| K010772 | Isi-2500 Ccd C-Arm, Isi-2500 Plus Ccd C-Arm | Imaging Services, Inc. | JAA | Class II | |
| K012757 | Iti Dental Implant System | Straumann USA, LLC | DZE | Class II | |
| K012533 | Modification to Osi Medical Dolphin Stand-Alone Pulse Oximeter and Accessories | Osi Medical, Inc. | DQA | Class II | |
| K012310 | Modification To:hl168d Blood Pressure Monitor | Health & Life Corporation | DXN | Class II | |
| K012305 | Modification to: Trinica Anterior Cervical Plate System | Zimmer Spine, Inc. | KWQ | Class II | |
| K012303 | Jel-20 | J.F. Jelenko & Co., Inc. | EJS | Class II | |
| K012224 | Single Action Biopsy Needle, Model Rcbs: Xx Gauge, Xx Length, Xx Throw | Ranfac Corp. | KNW | Class II | |
| K012129 | Ortho Development Orion-I Emf System | Ortho Development Corp. | GEI | Class II | |
| K011941 | Excilon Amd Antimicrobial Sponge Model #7088 | Kendall | FRO | Unclassified | |
| K011856 | Radiographic Markers | Encore Orthopedics, Inc. | NEU | Class II | |
| K011817 | Bridge Fx | Medtronic, Inc. | FGE | Class II | |
| K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | DXT | Class II |