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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K811395 | Empi Model 710, Nms | Empi | IPF | Class II | |
| K811210 | Yoshida-Panoura 10 | Kaycor Intl., Ltd. | |||
| K812180 | Life-Tech #5102 Visulab | Life-Tech Instruments, Inc. | GWN | Class II | |
| K810740 | Argon Microsurigal Protocols | Lumenis Ltd | EWG | Class II | |
| K810660 | Kremer Corneometer Ultrasonic Pachometer | Accutome, Inc. | IYO | Class II | |
| K812255 | Ethicon Lacrimal Stent | Ethicon, Inc | HNL | Class I | |
| K812252 | Latex Leg Bag-57.Xx | Manfred Sauer Corp. | KNX | Class II | |
| K812251 | Disposable Urine Gab-70.Xx | Manfred Sauer Corp. | KNX | Class II | |
| K812250 | Condom-52.Xx | Manfred Sauer Corp. | KNX | Class II | |
| K812246 | Coat-a-Count T3 Ria Kit | Siemens Healthcare Diagnostics Inc. | CDP | Class II | |
| K812231 | Intravenous Administration Set | Cordis US Corp. | FPA | Class II | |
| K812216 | Cuddle Cap | Darcy, Inc. | LDQ | ||
| K812197 | Emit-St Cannabinoid Calibrator | Syva Co. | DLJ | Class II | |
| K812196 | Emit-St Cannabinoid Controls | Syva Co. | LAS | Class I | |
| K812195 | Emit-St Cannabinoid Assay | Syva Co. | LDJ | Class II | |
| K812156 | Concep-7-Bhcg | Leeco Diagnostics, Inc. | JHI | Class II | |
| K812154 | Medtronic #3484 Pisces Epidural Lead | Medtronic, Inc. | GZB | Class II | |
| K812140 | Bird Mean Airway Pressure Monitor | 3M Company | CAP | Class II | |
| K812139 | Vacuum Suction Filter | K & G Healthcare Ind., Inc. | KDQ | Class II | |
| K812138 | TENS Device | Western Advanced Technology, Inc. | GZJ | Class II | |
| K812114 | Lifecare 1000 Controller | Abbott Medical | LDR | Class II | |
| K812107 | Renalab Transducer Protector, .22 Micron | Renalab | FIB | Class II | |
| K812092 | Beta Post | Paul B. Heller, D.M.D. | ELR | Class I | |
| K812061 | Model S10vs Visual Stimulator | Grass Instrument Co. | GWE | Class II | |
| K812001 | Oscillaire | Jones Medical Instrument Co. | BZC | Class II | |
| K811871 | Bactericidal Incise Drape | Surgikos, Inc. | KKX | Class II | |
| K811764 | Uric Acid Reagent Set | Anco Medical Reagents & Assoc. | LFQ | Class I | |
| K811510 | Gore-Tex Vasular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K811499 | Tensmax | Anritsu America Co. | GZJ | Class II | |
| K811427 | Superfil Light & Superfil Bonding System | Harry J. Bosworth Co. | EBF | Class II | |
| K811365 | Hill Top Chamber | Hill Top Research, Inc. | KXF | Class I | |
| K811347 | Dicon Auto Perimeter 2000 | Dicon, Inc. | HPT | Class I | |
| K811346 | Dicon Auto Perimeter 200 | Dicon, Inc. | HPT | Class I | |
| K812220 | Nephelometric Solid Turbidity Standard | Hyland Therapeutic Div., Travenol Laboratories | JIW | Class II | |
| K812183 | Timeter-Produced Puritan Bennett Air Adp | Timeter Instrument Corp. | CAX | Class I | |
| K812182 | Miami, Protrusio Ring | Zimmer GmbH | JDI | Class II | |
| K812173 | Flushflo II | Bentley Laboratories, Inc. | KRA | Class II | |
| K812166 | Percussor | Dhd Medical Products Div. Diemolding Corp. | BYI | Class II | |
| K812157 | Lkb-Bromma 2218 Historange Microtome | Lkb Instruments, Inc. | IDO | Class I | |
| K812143 | Introducer, Percutaneous | Willson | DYB | Class II | |
| K812128 | Recon 1 | Precision Metering, Inc. | CAX | Class I | |
| K812101 | Bak-on Sp Porcelain Alloy | Johnson & Johnson Professionals, Inc. | EJS | Class II | |
| K812098 | Mini Nicholes | Healthcare Ind. | CAH | Class II | |
| K812097 | Koi Lacremal Hook & Dilator | Koi, Inc. | HNW | Class I | |
| K812077 | Helena Sickle-Thal Quik Column Method | Helena Laboratories, Corp. | JPD | Class II | |
| K812070 | Bores* Adjustable Blade Holder | Santa Barbara Medco, Inc. | GDZ | Class I | |
| K812063 | Sr-1V Data Printer | American Optical Corp. | HKO | Class I | |
| K812053 | Silastic Hemi Wrist Implant H.p. (Rad.) | Dow Corning Corp. Healthcare Industries Materials | KXE | Class II | |
| K812048 | Ids Rapids Nh Systems | Carr-Scarborough Microbiologicals, Inc. | JSX | Class I | |
| K812032 | Mevatron 67E | Siemens Medical Laboratories, Inc. | IYE | Class II |