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 |
|---|---|---|---|---|---|
| K000527 | Accuclot Drvvt Screen, Catalog No. A6094 | Sigma Diagnostics, Inc. | GIR | Class I | |
| K000525 | Hardydisk Ofloxacin 5Mcg | Hardy Diagnostics | JTN | Class II | |
| K000524 | Hardydisk, Cefotaxime 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000509 | Hardydisk, Vancomycin 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000449 | Screeners Benzodiazepine (Bzd) Test, Drug Screen Dip Benzodiazepine (Bzd) Test | Drug Detection Devices, Ltd. | JXM | Class II | |
| K000440 | Hardydisk Ceftriaxone 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000273 | Screeners Opiates Test Drugscreen Dip Opiates Test | Drug Detection Devices, Ltd. | DJG | Class II | |
| K000272 | Hardydisk, Nitrofurantoin | Hardy Diagnostics | JTN | Class II | |
| K000271 | Hardydisk, Sulfa/trimeth | Hardy Diagnostics | JTN | Class II | |
| K000268 | Hardydisk, Ampicillin, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K000261 | Hardydisk, Piperacillin/tazobactam, 110Mcg | Hardy Diagnostics | JTN | Class II | |
| K000177 | Renegade Hi-Flo Microcatheter | Boston Scientific Corporation | KRA | Class II | |
| K000061 | Minxray Hf70d High Frequency Portable Dental X-Ray Unit | Minxray Inc | EHD | Class II | |
| K993027 | Eska Modular Hip System | Specs USA, Inc. | LPH | Class II | |
| K992154 | Bicon-Plus Acetabular Components | Plus Orthopedics | LPH | Class II | |
| K991060 | Zynergy Zolution Electrophysiology Catheter, Model Z50000 | Zcv,Inc. | DRF | Class II | |
| K983657 | Osteonics Series 7000 Ad Tibial Tray | Osteonics Corp. | HRY | Class II | |
| K982556 | Leveen Needle Electrode | Radiotherapeutics Corp. | GEI | Class II | |
| K000941 | Sterltech Water Purifier | Sterltech, Inc. | EIA | Class I | |
| K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and Compact Portable Patient Monitor | Agilent Technologies, Inc. | DSI | Class II | |
| K000764 | Pediatric Fixation Rods | Zimmer GmbH | JDS | Class II | |
| K000763 | Px 53/15-Bp, Model 130 050 and Px 60/15-Bp, Model 130 051 | BIOTRONIK AG | DTB | Class III | |
| K000753 | Cordis 13F Catheter Sheath Introducer | Cordis US Corp. | DRF | Class II | |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer Lubricant | Armkel, LLC | HIS | Class II | |
| K000532 | Jel 15 | J.F. Jelenko & Co., Inc. | EJS | Class II | |
| K000462 | Urine Phencyclidine (Pcp) Screen Flex Reagent Cartridge, Catalog No. Df 94A | Siemens Healthcare Diagnostics Inc. | LCM | Unclassified | |
| K000461 | Urine Cannabinoids (Thc) Screen Flex Reagent Cartridge, Catalog No. Df 95A | Siemens Healthcare Diagnostics Inc. | LDJ | Class II | |
| K000213 | Jeldent Basic Line | J.F. Jelenko & Co., Inc. | ELM | Class II | |
| K992781 | Architech Afp Mastercheck, Model 6C01-05 | Bio-Rad | JJX | Class I | |
| K000951 | Luxaform | Dmg USA, Inc. | EBG | Class II | |
| K000908 | Skylight Imaging System | Philips North America LLC | KPS | Class II | |
| K000872 | Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color | Shanghai Antares Industries, Inc. | LYZ | Class I | |
| K000725 | Hwa (and) Silktex Powder-Free Latex Examination Glove with Protein Labeling Claim (50 Microgram or Less) | Hwa Teh Industrial Sdn. Bhd. | LYY | Class I | |
| K000629 | Flextime | Kulzer GmbH | ELW | Class II | |
| K000595 | Dimension Penta L | Espe Dental AG | ELW | Class II | |
| K000534 | Cobas Integra Reagent Cassette for Rheumatoid Factor II | Roche Diagnostics GmbH | DHR | Class II | |
| K000489 | Enzyme Immunoassay Anti-Centromere Antibody Test | Helix Diagnostics, Inc. | LLL | Class II | |
| K000466 | Urine Methadone (Meth) Screen Flex Reagent Cartridge, Catalog No. Df 93A | Siemens Healthcare Diagnostics Inc. | DJR | Class II | |
| K000375 | Randox Calcium | Randox Laboratories, Limited | CIC | Class II | |
| K000330 | Nitrile Patient Examination Glove (Green Color), Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K000329 | Nitrile Patient Examination Glove Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K000323 | Nitrile Patient Examination Glove (Blue Color) Powder Free, Non Sterile | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K000235 | Insyte Catheter, Insyte Autoguard Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K000051 | Acticoat Foam Dressing | Westaim Biomedical, Inc. | FRO | Unclassified | |
| K994065 | Ms-One, Model Ms-1 | Home Wellness West | IPF | Class II | |
| K000414 | Medisul Disposable Vaginal Speculum | Marketing Perspectives | HIB | Class II | |
| K000113 | Proven Knee System | Globus Medical, Inc. | JWH | Class II | |
| K000049 | Suni Max | Satelec | EFB | Class I | |
| K000029 | Stela Ut46 and Bt45/46 Straight Tined Pacing Leads, Stela Uj45 and Bj44/45 J-Shaped Tined Pacing Leads | Ela Medical, Inc. | DTB | Class III | |
| K000028 | Renaflo II HF 2000 Hemofilter | Medivators Inc | KDI | Class II |