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 |
|---|---|---|---|---|---|
| K944334 | Varelisa Combined DNA Antibodies Eia | Elias U.S.A., Inc. | LRM | Class II | |
| K943580 | Autostat II Anti-Tpo | Cogent Diagnotics, Ltd. | JNL | Class II | |
| K951418 | Lorrex Gauze Pads (1'S) and Lorrex Gauze Sponges - Sterile 2'S and Sterile 10'S and Non-Sterile | Lorons International Corp. | EFQ | Unclassified | |
| K951377 | Resound Personal Hearing System Btp/s-a W/remote Control Option | Resound Corp. | ESD | Class I | |
| K951376 | Resound Personal Hearing System Bt2/s Series W/remote Control Option | Resound Corp. | ESD | Class I | |
| K951375 | Resound Personal Hearing System Ed3/s-E | Resound Corp. | ESD | Class I | |
| K951374 | Resound Personal Hearing System Bt2/s-E | Resound Corp. | ESD | Class I | |
| K951367 | Porta-Screen Spirometer | S & M Instrument Co. | BZG | Class II | |
| K951345 | Disposable Airway Connectors for Gas Sampling | Biomerics | BZA | Class I | |
| K951000 | Ztt I and II Acetabular Cup of the S-Rom Total Hip System | Joint Medical Products Corp. | LPH | Class II | |
| K950777 | Oxygen Regulator | Mada Medical Products, Inc. | CAN | Class I | |
| K950462 | Gauze, Nonabsorable, Non-Medicated (Internal Sponge) | Spring Intl., Inc. | EFQ | Unclassified | |
| K950397 | System 22 Valve | Turnkey Intergration USA, Inc. | BYE | Class II | |
| K950328 | Amoxicillin/clavulanic Acid 2/1 | Ab Biodisk North America, Inc. | JWY | Class II | |
| K950316 | Cordis Steerable Guidewires | Cordis US Corp. | DQX | Class II | |
| K950308 | Stc Diagnostics Auto-Lyte(r) Methaqualone Eia | Solarcare Technologies Corp,Inc. | JXS | Class I | |
| K950266 | Scimed(r) Choice(tm) Pt Exchange Ptca Guide Wire | Scimed Life Systems, Inc. | DQX | Class II | |
| K950257 | Multiple (Izon Dbs & Urine Collection Kit) | Izon Business Products, Inc. | JXA | Class I | |
| K950167 | Premier Ehec | Meridian Diagnostics, Inc. | GNA | Class I | |
| K950159 | Suresharp | Gainor Medical U.S.A., Inc. | FMI | Class II | |
| K945639 | Spetzler Pin | Howmedica Corp. | HTY | Class II | |
| K945629 | Micos Micropulse(tm) Alternating Pressure Mattress | Micos Medical Systems | FNM | Class II | |
| K945454 | Leur Tip Cap, Vlt Cap(tm) | Martell Medical Products, Inc. | JKA | Class II | |
| K945426 | Arthrex Cancellous Screw and Washer | Arthrex GmbH | HWC | Class II | |
| K943883 | Saxon Gold Ultra Spermicidal Rainbow Condom | Aladan Corp. | HIS | Class II | |
| K943681 | Steri-Oss Scaler for Dental Implants | Steri-Oss, Inc. | DZE | Class II | |
| K941709 | Acufex Arthroscopic Discectomy Systems | Acufex Microsurgical, Inc. | HRX | Class II | |
| K941616 | Variant Total Ghb Program | Bio-Rad | LCP | Class II | |
| K940009 | Gemscom Series 6000, Models 6100, 6200 & 6300 | General Devices | DRG | Class II | |
| K935704 | Dried Gram-Negative Mic//combo Panels | Baxter Diagnostics, Inc. | LTT | Class II | |
| K934795 | Card Guard | Card Guard Scientific Survival, Ltd. | BZH | Class II | |
| K931615 | Nite-Guide | Ortho-Tain, Inc. | KMY | Class I | |
| K930013 | CO2 Insufflator 1100 | Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz | HIF | Class II | |
| K951255 | Imedge Video Ostoscope (Analog) | Introspect, Inc. | ERA | Class I | |
| K951171 | Scipotex | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K951137 | Comfit Fpowder Free Examination Glovers (Hypoallergenic) | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K951135 | Multi-Drug Control Set | Microgenics Corporation | DIF | Class I | |
| K951034 | Aura Laser System | Laserscope | GEX | Class II | |
| K950998 | Moduilar Unipolar | Intermedics Orthopedics | KXA | Class II | |
| K950677 | Atrium Dry Suction Control Water Seal Chest Drain | Atrium Medical Corporation | KDQ | Class II | |
| K950659 | Ultracell Retractor Covers | Ultracell Medical Technologies, Inc. | GDY | Class I | |
| K950540 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | FZP | Class II | |
| K950406 | Device, Electrosurgical, Cutting and Coagulation & Accessories | Apyx Medical Corporation | GEI | Class II | |
| K950281 | Mesh Matrix Wound Dressing | Brennen Medical, Inc. | KGN | Unclassified | |
| K950212 | A2 Detached Dual Port System | Therex Corp. | LJT | Class II | |
| K950211 | Elsa-Pth | Cis-Us, Inc. | CEW | Class II | |
| K950185 | Tactylon(tm) Powder Free Surgeons Glove | Tactyl Technologies, Inc. | KGO | Class I | |
| K950164 | Piccolo(tm) Primary Health Panel Reagent Rotor | Abaxis Inc | CHH | Class I | |
| K950137 | Urine Barbiturates Screen Flex(tm) Reagent Cartridge | E.I. Dupont de Nemours & Co., Inc. | DIS | Class II | |
| K950133 | Hypodermic Syringe Piston | Ispg, Inc. | FMF | Class II |