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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K810347 | Bosch Star 66F Super Earlevel Aid | Bosch Hearing Instruments, Inc. | ESD | Class I | |
| K810313 | Haemonetics 1400 Ml Therapeutic Bag | Haemonetics Corporation | KSR | Class II | |
| K810570 | Dressing Change Tray-Medium | Associated Medical Products Co. | LDQ | ||
| K810225 | Litronic Stimulator | Med-Western Electronics, Inc. | IPF | Class II | |
| K810763 | Ohio Disposable Tracheal Tube | Airco/Ohio Medical Products | BTR | Class II | |
| K810750 | Pds Cardiac Calc. Softw. Progr. #A3604ae | General Electric Co. | DQK | Class II | |
| K810732 | Linde Mark II Oxygen Reserv. Type or-4 | Union Carbide Corp. | BYJ | Class II | |
| K810731 | Model Im1000 Integrated Monitor | Gould, Inc. | DQK | Class II | |
| K810730 | Model Sp5107 Thermodilution Catheter | Gould, Inc. | KRB | Class II | |
| K810696 | Physiologic Recorder | Honeywell, Inc. | DPS | Class II | |
| K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | DQX | Class II | |
| K810663 | Leeco Fsh-Quant Diagnostic Kit | Leeco Diagnostics, Inc. | CGJ | Class I | |
| K810661 | Cathdamp | MEDLINE INDUSTRIES, LP - Northfield | DRS | Class II | |
| K810654 | Stopperless Hot/cold Rubber Water Bottle | First Industries, Inc. | FDF | Class II | |
| K810653 | Vinyl Ice Bag | First Industries, Inc. | KYR | Class I | |
| K810631 | Dpm Calculator | Iso-Data, Inc. | JQP | Class I | |
| K810625 | Human Placental Lactogen Radioimmuno- | Serono Laboratories, Inc. | DHI | Class I | |
| K810619 | 710 Fluorometer/densitometer | Corning Medical & Scientific | JQT | Class I | |
| K810352 | Swan-Ganz Flow-Directed Thermodilution | American Edwards Laboratories | DYG | Class II | |
| K810204 | 17B Estradiol | Pantex, Div. Bio-Analysis, Inc. | CHP | Class I | |
| K810113 | Terfusion Final Filter Set | Terumo Medical Corp. | FPB | Class II | |
| K803270 | Ganz Coronary Reperfusion Catheter | American Edwards Laboratories | DQO | Class II | |
| K810693 | Curity Perineal Cold Pack | The Kendal Co. | IMD | Class I | |
| K810692 | Curity Perineal Warm Pack | The Kendal Co. | IMD | Class I | |
| K810685 | Suture Removal Kit | Medical Action Industries, Inc. 306 | GEN | Class I | |
| K810681 | Medi-Lance | Medicore Co. Ltd. | FMK | Class II | |
| K810676 | Convaid Cruiser Cp4m | Convaid Products LLC | LBE | Class I | |
| K810650 | Crutch Tips & Grips | First Industries, Inc. | INP | Class I | |
| K810649 | Invalid Cushion | First Industries, Inc. | KIC | Class I | |
| K810633 | Wonder Warmer | Montvale Products, Inc. | IMD | Class I | |
| K810623 | Band-Aid Kitchen Assortment | Johnson & Johnson Professionals, Inc. | KGX | Class I | |
| K810579 | Adhesive i.v. Catheter Dressing | Johnson & Johnson Professionals, Inc. | KMK | Class I | |
| K810520 | Insall/burstein Constrained Total Condyl | Zimmer GmbH | KRO | Class II | |
| K810475 | Helena Hemoglobin F Controls | Helena Laboratories, Corp. | KQI | Class II | |
| K810154 | Lifepak 7 Acute Cardiac Care System | Physio Control, Inc. | DPS | Class II | |
| K810114 | Vascular Access System | Bentley Laboratories, Inc. | FIQ | Class II | |
| K810050 | Vecafix* | Pollak (Intl.).ltd | KGX | Class I | |
| K810027 | Datamedix Pecgasys System | Datamedix | DSI | Class II | |
| K810712 | Electronic Spirometer Model Mfr-8100 | Nihon Kohden America Inc | BTY | Class II | |
| K810671 | Ccpd 3 Liter Drainage Set | American Medical Products LLC | KDJ | Class II | |
| K810670 | Ccpd Cycler Set | American Medical Products LLC | KDJ | Class II | |
| K810644 | Hoffman Hoop Device | Howmedica Corp. | |||
| K810611 | Fulcast/summit Casting Alloy | C.Vaupel Dental, Inc. | EJH | Class II | |
| K810600 | Capd Exchange Set | American Mcgaw | KDJ | Class II | |
| K810595 | Silux Restorative Material & Enamel Bond | 3M Company | EBF | Class II | |
| K810594 | Crystalloy-P | Shofu Dental Corp. | EJH | Class II | |
| K810587 | Emit-Tfg Prisma Thyroxine Calibrators | Syva Co. | JIS | Class II | |
| K810585 | Sara | Allied Medical LLC | CBS | Class II | |
| K810545 | Pca Periocare Periodontal Dressing | Pulpdent Corp. of America | EMA | Class II | |
| K810531 | Peri-Patch Peritoneal Catheter Extension | Quinton, Inc. | KGZ | Class I |