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 |
|---|---|---|---|---|---|
| K951945 | Prosys Leg Bag | Convatec, A Division of E.R. Squibb & Sons | FAQ | Class I | |
| K951865 | Ultra Spherical Amalgam Alloy | Goldsmith & Revere, Inc. | EJJ | Class II | |
| K951836 | Compolglass Compoglass Sca | Ivoclar North America, Inc. | EBF | Class II | |
| K951513 | Jai | Intl. Trade Management Co. | LYY | Class I | |
| K951355 | Link Saddle Prothesis | Turnkey Intergration USA, Inc. | KWL | Class II | |
| K951140 | Kordklamp Umbilical Cord Clamp Applicator | Balagan Medical, Inc. | HFW | Class II | |
| K951106 | Silicone Foley Catheter | Cook Incorporated | EZL | Class II | |
| K950963 | Audiotech Model Spi | Muskogee Regional Hearing Aid Lab | ESD | Class I | |
| K950961 | Ksea Disposable Tubing Sets for the Hamou Endomat Pump | Karl Storz Endoscopy-America, Inc. | HIG | Class II | |
| K950872 | Cardon Physical Therapy Table Model: R27841 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950835 | Scimed Choice Pt Ptca Guide Wire | Scimed Life Systems, Inc. | DQX | Class II | |
| K950814 | Quest Antegrade Cardioplegia Cannula | Quest Medical, Inc | DWF | Class II | |
| K950763 | Lowe Klearway | Dr. Alan A. Lowe, Inc. | LRK | Class II | |
| K950708 | Lifetrace Intrauterine Pressure Catheter Iup 3000 | Graphic Controls Corp. | KXO | Class II | |
| K950702 | Laparoscopic Clamp | Applied Medical Resources Corp | GCJ | Class II | |
| K950542 | Metal Backed Acetabular Component | Encore Orthopedics, Inc. | JDL | Class III | |
| K950142 | Cr Perfect | Chimera Research & Chemical, Inc. | CGX | Class II | |
| K946225 | 3M Filtrete(tm) Air Filter Media | Tagg Industries | CBP | Class II | |
| K946147 | Kse Steiner Electromechanic Morcellator | Karl Storz Endoscopy-America, Inc. | HET | Class II | |
| K945844 | Depuy Cdh Prosthesis | Depuy, Inc. | MEH | Class II | |
| K945755 | Orex(r) o.r Equipment Drapes | Thantex Specialties, Inc. | KKX | Class II | |
| K945622 | Mca(tm) 180 Hemodialyzer | Althin Medical AB an Affiliate of Baxter Intl | FJI | Class II | |
| K945213 | Teen 100 | Aerosport, Inc. | BZC | Class II | |
| K943662 | Laparascope | Pollux Endoscopy, Inc. | HET | Class II | |
| K943052 | Arthroscopic Telescopes | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K942534 | Gerber Natural Comfort Battery Breast Pump | Gerber Products Co. | HGX | Class II | |
| K951995 | Karl Storz Catheters, Mandrin, Plugs, Connector | Karl Storz Endoskop GmbH | KNY | Class II | |
| K951971 | Xenon Light Source | Envision Medical Corp. | GCT | Class II | |
| K951895 | Accu-Beam 300W Xenon Light Source | Tti Medical | GCT | Class II | |
| K951883 | Planmed Sophie Mammographic X-Ray Unit | Planmed Oy | IZH | Class II | |
| K951875 | Strato/infusaid Button Port Vascular Acc. System | Strato/Infusaid, Inc. | LJT | Class II | |
| K951732 | Nezhat-Doresey Pencil-Grip Handles | American Hydro-Surgical Instruments, Inc. | GEI | Class II | |
| K951596 | Earclear | Arisil Medical | MJV | Unclassified | |
| K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures | Karl Storz Imaging, Inc. | GCJ | Class II | |
| K950807 | Sunblocker Sunglasses | Blublocker LLC | HQY | Class I | |
| K950721 | Fuji Medical Laser Imagermulti-Formatters Mf-300 and Mf-300L | FUJIFILM Healthcare Americas Corporation | LMC | Class II | |
| K950687 | External Helium Supply (Accessory for Iabp) | Belmont Medical Technologies | DSP | Class II | |
| K950611 | Expert Morphomerty Softward | Lunar Corp. | KGI | Class II | |
| K950106 | Coltolux Light Meter | Coltene /Whaledent AG | EBZ | Class II | |
| K946081 | Fluorex Dta-400A | Toshiba America Medical Systems, In.C | JAA | Class II | |
| K945796 | Sharplan Usight 9010 Laparoscopic Ultrasound System | Sharplan Lasers, Inc. | ITX | Class II | |
| K945792 | Im512p | Globus Industries | IYX | Class I | |
| K945698 | Coltolux 3, Coltolux 4 | Coltene /Whaledent AG | EBZ | Class II | |
| K945413 | Medtronic Model 3864C & 3865C Temporary Screening Lead/catheter Kit | Medtronic, Inc. | MAJ | Class II | |
| K945155 | Airis | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K944485 | 4000 Au Ultrasound Imaging System | Biosound, Inc. | IYO | Class II | |
| K944422 | Bsm-8800A Bedside Monitor | Nihon Kohden America Inc | DSI | Class II | |
| K943808 | Rionet Hm-02 | Rockwin Corp. | ESD | Class I | |
| K943559 | Remote A'lert | Health Sense Intl., Inc. | KPN | Class II | |
| K943558 | Pro'tect | Health Sense Intl., Inc. | KPN | Class II |