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 |
|---|---|---|---|---|---|
| K955890 | First Medic Pulse Oximetry Module | Colorado Medtech, Inc. | MKJ | Class III | |
| K972490 | D'arc Eye Care Sunglasses | M & R Dist. | HQY | Class I | |
| K972408 | Cardiac Status Controls | Spectral Diagnostics, Inc. | JJT | Class I | |
| K972302 | Pocket Count or Safetcount | Sage Products LLC | LWH | Class I | |
| K972144 | Sigma Diagnostics Accucolor Antithrombin III | Sigma Diagnostics, Inc. | JBQ | Class II | |
| K972123 | Protective Restraint Models #302,440,750,850,And905 | Smith | FMQ | Class I | |
| K972116 | Von Willebrand Reagent | Behring Diagnostics, Inc. | GGP | Class II | |
| K972074 | Suction Instrumentation | Biomet Microfixation | GCX | Class II | |
| K971792 | Immulite Free T4 (2-Step) | Siemens Healthcare Diagnostics Inc. | CEC | Class II | |
| K971664 | Ramy Piston Syringe | Alshifa Medical Syringes Mfg. Co., Ltd. | FMF | Class II | |
| K971660 | Olympus Gf-Um130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment | OLYMPUS Corporation of the Americas | FDS | Class II | |
| K971545 | Protege Liquid Oxygen System | Healthdyne Technologies, Inc. | BYJ | Class II | |
| K971533 | Vibra-Surge System Model Vs2120 | Sonics & Materials, Inc. | LFL | Unclassified | |
| K970375 | Annuloflo System | Carbomedics, Inc. | KRH | Class II | |
| K970080 | Arrow-Trerotola Ptd Catheter | Arrow Intl., Inc. | MCW | Class II | |
| K965167 | Percutaneous Venous Introducer 10264 | Greatbatch Medical | DYB | Class II | |
| K964351 | Elecsys Psa Assay | Boehringer Mannheim Corp. | LTJ | Class II | |
| K972452 | Ramy Integrated Needle Syringe | Alshifa Medical Syringes Mfg. Co., Ltd. | FMF | Class II | |
| K972433 | Cedia Digoxin Calibrators | Boehringer Mannheim Corp. | DLJ | Class II | |
| K972348 | Hp Endovaginal/endorectal Probe, Hp Image Point Ultrasound System | Hewlett-Packard Co. | ITX | Class II | |
| K972338 | Protective Restraint(models #302,440,750 and A30 X 30 Belt. | Geriatric Products, Inc. | FMQ | Class I | |
| K972172 | Esr Control-M Hematology Erythrocyte Sedimentation | R & D Systems, Inc. | JPK | Class II | |
| K972170 | Esr Control-Hc Hematology Erythrocyte Sedimentation | R & D Systems, Inc. | JPK | Class II | |
| K972012 | Cholestech Bun/creatinine Test System | Cholestech Corp. | CDN | Class II | |
| K971849 | Cytology Brush | Team Technologies, Inc. | HHT | Class II | |
| K971825 | Pancreatic Amylase, Ethylidene Blocked-Pnpg7 Enzyme Colorimetric Test | Randox Laboratories, Limited | JFJ | Class II | |
| K971789 | Implex Continuum Porous Patellar | Implex Corp. | JWH | Class II | |
| K971742 | Depuy Orthotech Heavy Duty Vest Restraint | Depuy, Inc. | FMQ | Class I | |
| K971668 | Signa Profile Wrist Coil and Mobile Siting Options | GE Healthcare | LNH | Class II | |
| K971642 | Dentalis Kez Endodonitc Sealer | Neodental Chemical Products Co., Ltd. | EMA | Class II | |
| K971615 | Pattison Esophageal Dilator | Tri-Med Specialties, Inc. | KNQ | Class II | |
| K971607 | Medi-Tech 4 and 5 French Nighthawk Flush Angiographic Catheters | Boston Scientific Corporation | DQO | Class II | |
| K971589 | Reach Antibacterial Toothbrush | Personal Products Co. | EFW | Class I | |
| K971518 | Ksea Semi-Rigid Hysteroscope and Accessories | Karl Storz Endoscopy-America, Inc. | HIH | Class II | |
| K971512 | Ams Coaguloop Resection Electrode | American Medical Systems, Inc. | FAS | Class II | |
| K971511 | Radionics Contour Flex Valve, Radionics Contour Flex Plus Valve | Radionics, Inc. | JXG | Class II | |
| K971180 | Bard No-Rinse Hemoconcentrator and Accessory Kit | C.R. Bard Inc | KDI | Class II | |
| K970989 | Cyberren | Cybernius Medical, Ltd. | KPF | Class II | |
| K964590 | Colormate III | Chromatics Color Sciences Intl., Inc. | MQM | Class I | |
| K964230 | Corelife | Core Healthcare, Ltd. | FMF | Class II | |
| K972543 | Twist Ppagc-1, Twist Pp | Trutone | ESD | Class I | |
| K972542 | Jazz Pp Agc-O, Jazz Pp | Trutone | ESD | Class I | |
| K972431 | Meridian Dsp | Micro-Ear Technology, Inc. | ESD | Class I | |
| K972400 | Myringotomy Tube - Bobbin with Tab | Mednet Locator, Inc. | ETD | Class II | |
| K972346 | Miracle-Ear Ite Digital | Miracle-Ear, Inc. | ESD | Class I | |
| K972345 | Dahlberg/miracle-Ear | Miracle-Ear, Inc. | ESD | Class I | |
| K972344 | Miracle-Ear Digital Bte | Miracle-Ear, Inc. | ESD | Class I | |
| K972333 | Ammonia/iron Standard Kit | Verichem Laboratories, Inc. | JIX | Class II | |
| K972202 | Deeg-Lite | Grass-Telefactor Product Group | GWQ | Class II | |
| K972159 | Fenwal 40 Micron Transfusion Filter | Baxter Healthcare Corporation | CAK | Class II |