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 |
|---|---|---|---|---|---|
| K973622 | Transducer Positioner | Protek Medical Products, Inc. | ITX | Class II | |
| K973402 | Steri-Oss 3.25 Mm Replace Dental Implant System | Steri-Oss, Inc. | DZE | Class II | |
| K973372 | Aurofilm 2000 | Metalor Dental USA Corp. | EJT | Class II | |
| K973366 | Cobra Hand Piece | Vidamed, Inc. | KNS | Class II | |
| K973299 | Pin Care Kit | Brown Medical Industries | EFQ | Unclassified | |
| K973295 | Biopolar Button Electrode, Wl 150Mm, W/suction Applicator/wl 280Mm, W/suction Applicator(8801.451 | Richard Wolf Medical Instruments Corp. | GEI | Class II | |
| K973268 | Microaire Power Aspiration Device Pad System | MicroAire Surgical Instruments, LLC | BTA | Class II | |
| K973249 | Endoassist | Armstrong Healthcare Limited | GCJ | Class II | |
| K973239 | Dicom 3.0 Software Version 2.0 | Philips North America LLC | LMD | Class I | |
| K972945 | Aurenorm 68 | Aurex Precious Metal Industries (Pty)Ltd | EJS | Class II | |
| K972206 | Nipro Blood Tubing Set with Transducer and Solution Set for Hemodialysis | Nipro Medical Corporation | KOC | Class II | |
| K972066 | Belzer-Mps | Trans-Med Corp. | KDN | Class II | |
| K971554 | Bodystat | Bodystat Ltd | MNW | Class II | |
| K970840 | Intelliflow Respiratory Analyzer | Simtec, Inc. | BZC | Class II | |
| K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt) | Aesculap Inc | HCH | Class II | |
| K964539 | Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-Nf, F800-F802, Ro Secura, Reverse Osmosis Syst | Zyzatech Water Systems, Inc. | FIP | Class II | |
| K974103 | Abbott Axsym Troponin-I | Abbott Medical | MMI | Class II | |
| K973541 | Medental Chemical Curing Sealant Pit & Fissure Tinted | Medental Intl. | EBC | Class II | |
| K973413 | Id. Store (Release 2.0) | I.S.G. Technologies, Inc. | LMB | Class I | |
| K973320 | Articulate Fitting System | Decibel Instruments, Inc. | EWO | Class II | |
| K973303 | Imation Model 9410 Network Interface | Imation Corp. | LMD | Class I | |
| K973270 | Leg'map Option | GE Healthcare | IZI | Class II | |
| K973233 | Image Fusion and Review System | Philips North America LLC | KPS | Class II | |
| K973230 | Monarch (in 2125)/Intellisystem (in 1125) | Merit Medical Systems, Inc. | DXT | Class II | |
| K973229 | D.o.r.c. Hexon Illumination System | Dutch Ophthalmic USA, Inc. | MPA | Class II | |
| K973228 | Sting Skin Prep Wipe(59420600)/sting Skin Prep Swab (59420700) | Smith & Nephew, Inc. | KMF | Class I | |
| K973216 | Favc-Hh: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (Rmds810t/815t/820t) | Rmds, Inc. | DXC | Class II | |
| K972456 | Rheumacol Rheumatoid Factor Test | Immunostics, Inc. | DHR | Class II | |
| K972063 | Whittingham Ultraclean Phaco Handpiece | William F. Whittingham | HQC | Class II | |
| K971110 | Tritest Reagent Cd3 Fitc/cd16+cd56 Pe/cd45 Percp;with Trucount Absolute Count Tubes | Becton Dickinson Immunocytometry Systems | GKZ | Class II | |
| K964276 | Endoscopic Hysterectomy and Uterus Manipulator | Richard Wolf Medical Instruments Corp. | HEW | Class II | |
| K974050 | Synchron Systems C-Reactive Protein (Crp) Reagent | Beckman Instruments, Inc. | DCK | Class II | |
| K973931 | Urea-Sl Assay Catalogue Number 239-10, 239-30 | Sekisui Diagnostics P.E.I. Inc. | CDQ | Class II | |
| K973901 | 17 B-Estradiol (Elisa) | Kmi Diagnostics, Inc. | CHP | Class I | |
| K973881 | Prospector Plus (Code Name : Rd-0508) | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K973746 | Pre-Filled Syringe for Koala Iup | Clinical Innovations, LLC | HFN | Class II | |
| K973696 | Synchron System Hemoglobin Alc Reagent | Beckman Instruments, Inc. | LCP | Class II | |
| K973694 | Provil Novo | Kulzer GmbH | ELW | Class II | |
| K973558 | Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus) | Ultracell Medical Technologies, Inc. | FEB | Class II | |
| K973462 | Softform Facial Implant | Tissue Technologies, Inc. | FTL | Class II | |
| K973371 | Certodyn Raecg Universal Adapter | B.Braun Medical, Inc. | DQY | Class II | |
| K973359 | Panoview Plus Telescope, 3.5Mm, O,wl 300Mm/25,wl 300Mm/0,wl 180Mm | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K973296 | Extend Hip Stem | Wrightmedicaltechnologyinc | JDI | Class II | |
| K973261 | Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head | Whiteside Biomechanics, Inc. | LZO | Class II | |
| K973254 | J-Tip Injector | National Medical Products, Inc. | KZE | Class II | |
| K973252 | Karl Storz Direct Coupled Camera Head | Karl Storz Imaging, Inc. | FET | Class II | |
| K973217 | Boston Liquid Enzymatic Cleaner | Polymer Technology Corp. | LPN | Class II | |
| K973205 | Wilson-Cook Stricture Measuring Catheter | Wilson-Cook Medical Inc. | ODD | Class II | |
| K973178 | Fluoro-Tex Surgical Membrane | Bridger Biomed, Inc. | DXZ | Class II | |
| K973103 | Chartermed Tpn-Eva Bags | Chartermed, Inc. | KPE | Class II |