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 |
|---|---|---|---|---|---|
| K930576 | At42 | Autoject Systems, Inc. | HCC | Class II | |
| K951668 | Scipotex/powder Free Examination Gloves | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K951667 | Comfit/green Powdered Examination Gloves | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K951662 | Comfit/beaded Surgeon's Glove | Wembley Rubber Products (M) Sdn Bhd | KGO | Class I | |
| K951661 | Profeel | Wembley Rubber Products (M) Sdn Bhd | KGO | Class I | |
| K951647 | Welch Allyn Hi - Lux Illuminator | Welch Allyn Inc | FCW | Class II | |
| K951629 | Imx Estradiol | Abbott Medical | JIS | Class II | |
| K951590 | Assure, Self-Sealing Sterilization Pouch | Sultan Chemists, Inc. | KCT | Class II | |
| K951450 | System 2000 Replacement Battery, System 2000-Extended Run Replacement Battery | Strenumed, Inc. | KIJ | Class I | |
| K951309 | Stone Dislodger, Basket | Boston Scientific Corporation | FGO | Class II | |
| K951228 | Ash-7000 | U.S. Table, Inc. | ITH | Class II | |
| K950907 | Pulse*spray Infusion System | Angiodynamics, Div. E-Z-Em, Inc. | QEY | Class II | |
| K950713 | Airguide Stylette | Polamedco, Inc. | BSR | Class I | |
| K950663 | Bei Medical Systems Mg-1000Hs Monopolar Generator | Bei Medical Systems Co., Inc. | GEI | Class II | |
| K950536 | Picis Chart+ | Picis | MHX | Class II | |
| K950487 | Graphic Controls Q-Trace Gold ECG Electrode | Graphic Controls Corp. | DRX | Class II | |
| K950486 | Graphic Controls Q-Trace ECG Electrode | Graphic Controls Corp. | DRX | Class II | |
| K950312 | Alpha System | Zimmer GmbH | JDI | Class II | |
| K950250 | Med-Surg Suture Washer | Medical Surgical, Inc. | HWC | Class II | |
| K950119 | Opta 5(Tm) 5F Pta Balloon Catheter | Cordis US Corp. | LIT | Class II | |
| K946273 | 1700 Monitoring ECG Electrode | Conmed Andover Medical, Inc. | DRX | Class II | |
| K946084 | Vanguard | Vanguard Container Corp. | FMI | Class II | |
| K945638 | Telphonic Stethoscope | American Telecare, Inc. | DQD | Class II | |
| K944592 | Precision Osteolock Femoral Component | Howmedica Corp. | LPH | Class II | |
| K943959 | Eclipse 4 Electrocardiograph | Burdick Corp. | LOS | ||
| K943696 | All Polyethylene Cemented Acetabular Cup | Depuy, Inc. | JDI | Class II | |
| K943601 | Comfit (Pink) | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K942351 | Di Isolation Gown | Derekduck Industries Corp. | FYC | Class II | |
| K942058 | Spacelabs Medical ECG Module (Model 90492) | GE Healthcare | DSI | Class II | |
| K951934 | Pfc Cement Restrictor | Johnson & Johnson Professionals, Inc. | LZN | Class II | |
| K951860 | Howmedice Bone Plug | Howmedica Corp. | LZN | Class II | |
| K951731 | Nezhat-Doresy Electrosurgical Hand Control Attachments | American Hydro-Surgical Instruments, Inc. | GEI | Class II | |
| K951625 | Karl Storz Koh Needle Holders, Forceps for Suturing, Suture Scissors, Tissue Probes, Injection Needle, Irrigation Instrt | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K951288 | Axsym Cannabinoids | Abbott Medical | JXM | Class II | |
| K951286 | Axsym Benzodiazepines | Abbott Medical | JXM | Class II | |
| K951214 | Sterile Equipment Cover | Gulfstream Medical | KKX | Class II | |
| K951182 | Ryder Contact Lens Case Model 10670 | Bradstreet Clinical Research Assoc., Inc. | LRX | Class II | |
| K951167 | Ems i.v. Start Kit | Emergency Medical Supply, Inc. | LRS | Class II | |
| K950934 | Mpm Hydrogel Dressing | Richard Hamer Assoc., Inc. | MGQ | Unclassified | |
| K950915 | Abbott Axsym II System | Abbott Medical | JJE | Class I | |
| K950909 | Transit-2 Infusion Catheter | Cordis Neurovascular, Inc. | DQO | Class II | |
| K950706 | Dryslide Coagulase | Difco Laboratories, Inc. | JTL | Class I | |
| K950681 | Model Turn Q Plus Automatic Turning Mattress with Low Air Loss Therapy | Invacare GmbH | IKZ | Class II | |
| K950455 | Device, Electrosurgical, Cutting and Coagulation & Accessories | Apyx Medical Corporation | JOS | Class II | |
| K950393 | Ace(tm) Cedia(r) Ferritin Assay | Schiapparelli Biosystems, Inc. | JMG | Class II | |
| K945651 | Liquichek(tm Immunology Control, Levels 1.2. and 3 | Bio-Rad | JJY | Class I | |
| K944856 | Orthomet Acetabular Roof Reinforcement Ring | Wrightmedicaltechnologyinc | HRS | Class II | |
| K944327 | Integral VI Biointegrated Dental Implant System | Calcitek, Inc. | DZE | Class II | |
| K941192 | Ortho Alt Microwell Test System | Ortho Diagnostic Systems, Inc. | CKD | Class I | |
| K936225 | Ts1 Turtle(tm) Syringe | Kershenstine Diamond, Inc. | MEG | Class II |