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 |
|---|---|---|---|---|---|
| K914619 | Cvm | Ciba Corning Diagnostics Corp. | JJY | Class I | |
| K914602 | Duran Flex Annuloplasty Ring/obtur H601h, Modified | The Heart Valve Div. Medtronic Cardiovascular Surg | KRH | Class II | |
| K914547 | Laparobag(tm) Tissue Retrieval System | Baxter Healthcare Corporation | GCJ | Class II | |
| K914527 | Cequal(tm) | General Electric Co. | KPS | Class II | |
| K914526 | Davol Endo-Flo Suct/irri Probe (for Gen Surgery) | Davol, Inc. | GCJ | Class II | |
| K914464 | Abbott Quickstart Sgpt, Item Number 5A43 | Em Diagnostic Systems, Inc. | CKA | Class I | |
| K914460 | Medtronic Model 5407S, 5807S & 5410S Surg Cables | Medtronic, Inc. | DRF | Class II | |
| K914352 | Cordis Obturator | Cordis US Corp. | DYB | Class II | |
| K914350 | Icon Computer System | Siemens Gammasonics, Inc. | JWM | Class II | |
| K914312 | Scimed 7Fr and 8Fr Triguide Guiding Catheters | Scimed Life Systems, Inc. | DQO | Class II | |
| K914281 | I-125 Seeds, Code: 6711 | Medi-Physics Inc. dba Nycomed Amersham Imaging | KXK | Class II | |
| K914268 | I-125 Seeds in Carrier, Code: 6720 | Medi-Physics Inc. dba Nycomed Amersham Imaging | KXK | Class II | |
| K914263 | Mrp-5000 & Mrp-7000 Hs/mr Quadrature Knee Coils | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K914225 | Aca(r) Beta-2-Microglobulin Calibrator | E.I. Dupont de Nemours & Co., Inc. | JZG | Class II | |
| K914211 | Cath Control | Highpoint Medical Corp. | KNY | Class II | |
| K914170 | Liquichek Therapeutic Drug Monitoring Control(tdm) | Bio-Rad | DIF | Class I | |
| K914134 | Incubator 8000 Sc | National Draeger, Inc. | FMZ | Class II | |
| K914101 | Circon Acmi Cat.# Lap 9900; High Flow Insufflator | Circon Video | HIF | Class II | |
| K914025 | Technicon Axon(tm) Systems, Alt(p 5-P)/ast(p 5-P) | Technicon Instruments Corp. | CIT | Class II | |
| K914018 | Abbott Quickstart Triglycerides Reagents, #5A33 | Em Diagnostic Systems, Inc. | CDT | Class I | |
| K914001 | Target Therapeutics Radiopaque Stylet | Target Therapeutics | DRB | Class II | |
| K913996 | Computerized Tomography X-Ray System Option | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K913932 | Percutaneous Dilator with Sheath | Interventional Therapeutics Corp. | FGE | Class II | |
| K913921 | Abbott Quickstart Alka Phosphatase (Alp) Item#5a38 | Em Diagnostic Systems, Inc. | CJE | Class II | |
| K913830 | Scimed 8 Fr. Triguideflex Guiding Catheters | Scimed Life Systems, Inc. | DQY | Class II | |
| K913829 | Olympus Flexible Tip Thoracoscope | Olympus Corp. | EWY | Class II | |
| K913812 | Omnifit/omniflex/odc/omnifit-Ha Hip Stem Series | Osteonics Corp. | JDI | Class II | |
| K913674 | Record and Verify Mevatron Adapter | Elekta Limited | IYE | Class II | |
| K913654 | Smith and Davis Pressure Therapy System | Smith & Davis Mfg. Co. | INX | Class II | |
| K913633 | Total Hip Prosthesis- Femoral Components | Intermedics Orthopedics | LZO | Class II | |
| K913536 | Prc Autopsy Device | Pennstate | KKX | Class II | |
| K913532 | Tx 3 TENS Modified | Globalcare/Bay Medical Corp. | GZJ | Class II | |
| K913442 | Medtronic 3625 Screener System | Medtronic, Inc. | GZB | Class II | |
| K913394 | Incubator 8000 Ic | Dragerwerk AG | FMZ | Class II | |
| K913305 | Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer | Unipath, Ltd. | GKZ | Class II | |
| K913269 | Osteo Bone Screws | Fred C. Bryson | HWC | Class II | |
| K913212 | 3M Ige Single Point Fast Test | Whittaker Bioproducts, Inc. | DHB | Class II | |
| K913052 | Itc Guiding Catheter | Interventional Therapeutics Corp. | DQY | Class II | |
| K912764 | Medtronic Model 3861 Temporary Screening Lead Kit | Medtronic, Inc. | GZB | Class II | |
| K912294 | Allergy Information Manager | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K912289 | Ultima Xs, Modification | American Imex | GZJ | Class II | |
| K912244 | Urotest Gph | In Wha Pharmaceutical Co., Ltd. | JII | Class II | |
| K912021 | Makar Mini Cannulated Cancellous Screws | Instrument Makar, Inc. | HWC | Class II | |
| K911993 | Mrh-500 | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K911893 | Easy Access Bed | Willis Therapeutic Innovations, Inc. | FNL | Class II | |
| K911872 | Philips Rigid Volume Coils | Philips North America LLC | LNH | Class II | |
| K911782 | Pumpman(tm) Ambulatory Drug Delivery System | Strato Medical Corp. | FRN | Class II | |
| K911378 | Townley Great Toe Joint | Biopro, Inc. | KWD | Class II | |
| K904798 | Suprapubic Flow Controller | Olympus Corp. | KOB | Class II | |
| K914858 | Ace Open-Back Halo Ring | Ace Medical | JEC | Class II |