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 |
|---|---|---|---|---|---|
| K965102 | Acromed Pedicle Screw | Acromed Corp. | MNH | Class II | |
| K964069 | Dsbas Option the Mammomat 3000 Mammography X-Ray System | Siemens Medical Solutions USA, Inc. | IZH | Class II | |
| K960441 | Steritec Integraph Model Ci-101 | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K970986 | Wako Direct Bilirubin V | FUJIFILM Healthcare Americas Corporation | CIG | Class II | |
| K970945 | Angled Tip Polypectomy Snare | United States Endoscopy Group, Inc. | KNS | Class II | |
| K970738 | Kodak Digital Science Cardiac Digital Acquisition Unit | Jamieson Film Co. | IZI | Class II | |
| K970684 | Lactate Dehydrogenase (Ld) | Randox Laboratories, Limited | CFJ | Class II | |
| K970432 | Infant Radiant Warmer - Models Iw910 and Iw920 | Fisher & Paykel Electronics, Ltd. | FMT | Class II | |
| K970249 | Simplex Airbrator | Simplex Medical Systems, Inc. | KOJ | Class II | |
| K964814 | Bipore Accuflex Percutaneous Sheath Introducer | Bipore, Inc. | DYB | Class II | |
| K963962 | Vista Brite Tip Catheters | Cordis US Corp. | DQY | Class II | |
| K963622 | Vail 2000 Enclosed Bed | Vail Products, Inc. | FNL | Class II | |
| K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | MQV | Class II | |
| K962317 | Magnes 2500 Wh Biomagnetometer | Biomagnetic Technologies, Inc. | OLY | Class II | |
| K954220 | Eub-8000 | Hitachi Medical Corp. of America | IYN | Class II | |
| K971466 | Synchron Cx Systems Gamma-Glutamyl Transferase Reagent (Ggt) | Carolina Liquid Chemistries | JQB | Class I | |
| K971338 | Syntec, Inc. Disposable Bare End Fiber | Syntec, Inc. | MPA | Class II | |
| K971326 | Arrow Company | Excel Eyewear Corp. | HQY | Class I | |
| K971249 | Golden State Imports International, Inc./ Coleman | Andrew G. Halpern | HQY | Class I | |
| K971217 | Instrument Tray Liner | General Hospital Supply Corp. | FSM | Class I | |
| K971108 | Alexander Manufacturing Co. Rechargeable Battery Part Number Ms721-P | Alexander Mfg. Co. | MSG | Class II | |
| K971104 | Classic Match | Delagar Division Belcam, Inc. | HQY | Class I | |
| K970944 | Barakka, Inferno, Sterling, And/or One | Sentinal Importing Corp. | HQY | Class I | |
| K970909 | Safe-Connect i.v. Set | Faulding Medical Device Co. | FPA | Class II | |
| K970899 | Safeskin Powdered Examination Glove | Safeskin Corp. | LYY | Class I | |
| K970895 | Custom Optical Sunglass Frames | Custom Optical Frames, Inc. | HQY | Class I | |
| K970878 | Endolight Fiberoptic Regular Monofilament and Fine Monofilament | American Medical Devices, Inc. | MPA | Class II | |
| K970848 | Siloc System | Kulzer GmbH | KLE | Class II | |
| K970794 | Latex Patient Examination (Powderfree Glove) | Siam Sempermed Corp., Ltd. | LYY | Class I | |
| K970759 | Solar Specs | Morris Rosenbloom & Co., Inc. | HQY | Class I | |
| K970698 | Boston Es Multivision (Enflufocon a) Contact Lens | Polymer Technology Corp. | HQD | Class II | |
| K970670 | Reusable Vitrectomy Probe | Altex Vision | HQE | Class II | |
| K970620 | Cordis Opta5 Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K970476 | Hwa Mao Optical Sunglasses (Non-Prescription) | Hwa Mao Optical Co., Ltd. | HQY | Class I | |
| K970463 | Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/arterial Reservoir | Terumo Medical Corp. | DTZ | Class II | |
| K970454 | Laxima International Limited Sunglasses | Laxima Intl., Ltd. | HQY | Class I | |
| K970368 | Sc9000/sc9015 Medical Information Bus (Mis) Protocol Converter | Siemens Medical Solutions USA, Inc. | DQA | Class II | |
| K970315 | Everest Sunglasses | YCC International | HQY | Class I | |
| K970104 | Sani-Shield | Dw Industries, Inc. | EFB | Class I | |
| K964976 | Flossbrush with Fluoride | Flossbrush Interdental Cleaner and Applicator | JES | Class I | |
| K964256 | Cygnus Instrument Protectors | Madison Polymeric Engineering | FRG | Class II | |
| K964188 | Healthcare Service and Supply Pva (Pneumatic Venous Augmentation) Foot Garment | Healthcare Service and Supply | JOW | Class II | |
| K964114 | Depuy Opti-Con and E-Z Shield Systems | Depuy, Inc. | FXX | Class II | |
| K964034 | Transjugular Access Set | Boston Scientific Corporation | DYB | Class II | |
| K964033 | 3F Angioptic Angiographic Catheter | Boston Scientific Corporation | DQO | Class II | |
| K963396 | Biosphere Suture Anchor | Instrument Makar, Inc. | MAI | Class II | |
| K960738 | Steritite Sealed Container(sc08f,sc06f,sc04f,sc08q,sc06q,sc04q,sc08h,sc06h,sc04h) | Engineered Custom Mfg., Inc. | KCT | Class II | |
| K955816 | Vigilance Continuous Cardiac Output/oximetry (Cco/svo2) Monitor | Baxter Healthcare Corporation | DYG | Class II | |
| K955622 | Automix Plus, 3+3, Micromix Compounding System; | Baxter Healthcare Corporation | LHI | Class II | |
| K971498 | Applied Medical Laparoscopic Guidewire | Applied Medical Resources Corp | EZB | Class I |