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 |
|---|---|---|---|---|---|
| K951119 | Nezhat-Dorsey Specimen Container System | American Hydro-Surgical Instruments, Inc. | GCX | Class II | |
| K951076 | Vital-Port Petite Dual Vascular Access System | Med Institute, Inc. | LJT | Class II | |
| K950386 | Model 3200P/3200pr Hyperbaric Chamber | Sechrist Industries Inc | CBF | Class II | |
| K946108 | Ear-a-Gator | Life-Tech Intl., Inc. | KHH | Class I | |
| K945787 | Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Endoscopic Arthroscopy Procedures | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K945688 | Valleylab Procision(tm) System | Medtronic, Inc. | GEI | Class II | |
| K945069 | Flexilog 2000 | Oakfield Instruments, Ltd. | FFT | Class I | |
| K944979 | Magnetic Resonance Diagnostic Accessory | GE Healthcare | LNH | Class II | |
| K944912 | Olympus Nbd Tubes | OLYMPUS Corporation of the Americas | FGE | Class II | |
| K944017 | Olympus Laparoscopic Ultrasound System | OLYMPUS Corporation of the Americas | ITX | Class II | |
| K943812 | Vidas Lyme Screen II | Biomerieux Vitek, Inc. | LSR | Class II | |
| K942927 | 0.035 in. Wise Wire | Boston Scientific Corporation | DQO | Class II | |
| K934164 | Model 2500E/2500er Hyperbaric Chamber | Sechrist Industries Inc | CBF | Class II | |
| K920186 | Water Purification System for Hemodialysis | Better Water, Inc. | FIP | Class II | |
| K952340 | Megabeam Aspirating Endocular Probe | Ceram Optec, Inc. | GEX | Class II | |
| K952266 | Schroeder Oral/nasal Directional Stylette | Stebar Instrument Corp. | BSR | Class I | |
| K952264 | Aslan Lapretract | Aslan Medical Technologies, Ltd. | GCJ | Class II | |
| K952084 | Humid-Vent Filter Pedi | Gibeck, Inc. | BYD | Class I | |
| K951842 | Bioderm Medical Transparent Film Dressing | Bioderm, Inc. | MGP | Unclassified | |
| K951791 | Depalor | Degussa AG | EJT | Class II | |
| K951790 | Pontallor 3 | Degussa AG | EJT | Class II | |
| K951788 | Degulor S | Degussa AG | EJT | Class II | |
| K951786 | Degulor a | Degussa AG | EJT | Class II | |
| K951165 | Sharplan Model 3100 Nd:yag Surgical Laser System | Sharplan Lasers, Inc. | GEX | Class II | |
| K951022 | Circulon System Step 1 | Convatec, A Division of E.R. Squibb & Sons | MCY | Class II | |
| K951021 | Circulon System Step 2 | Convatec, A Division of E.R. Squibb & Sons | MCY | Class II | |
| K950191 | The Lotecon Personal Care System | Lotecon, Inc. | FNM | Class II | |
| K945139 | Luhr Titanium Pan Fixation System | Howmedica Corp. | HRS | Class II | |
| K945137 | Luhr Titanium Alloy Pan Fixation System | Howmedica Corp. | HRS | Class II | |
| K944500 | Acufex Patellar Bone Block Sizer | Acufex Microsurgical, Inc. | HRX | Class II | |
| K943354 | Sutter Hammertoe Joint Prosthesis | Sutter Corp. | KWH | Class II | |
| K951986 | Insulated Electrosurgical Instruments | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K951859 | Acufex Endobutton Pack | Acufex Microsurgical, Inc. | HRX | Class II | |
| K951631 | Digoxin Assay for the Tecchnicon Ra/opera Systems in-Vitro Diagnostic Systems | Bayer Corp. | LFM | Class II | |
| K951391 | Il Test Digoxin, Pn 181761-00 | Instrumentation Laboratory Co. | KXT | Class II | |
| K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) Accessory | Vidamed, Inc. | GEI | Class II | |
| K951148 | Obsti-Hook | Onli | HGE | Class I | |
| K951069 | Sas Salmonella H B Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K950685 | Bioderm Medical Hydrocolloid Wound Dressing | Bioderm, Inc. | KMF | Class I | |
| K950237 | Digitest | Parkell, Inc. | EAT | Class II | |
| K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit | Incstar Corp. | LLM | Class I | |
| K946001 | Emergency Response Safety Kit | Ani Safety, Inc. | FXX | Class II | |
| K945891 | Karl Storz Knives, Curetts, Hooks, Probes | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K945837 | Sysmex(tm) F-820, 520 | Sysmex Corporation | GKZ | Class II | |
| K945800 | Y-Glutamyltransferase Assay, Catalogue Number 308-05 | Sekisui Diagnostics P.E.I. Inc. | JQB | Class I | |
| K945566 | Abbott Project I, Spectrum | Abbott Medical | JJE | Class I | |
| K936285 | Abbott Vision Glycated Hb, Modification | Abbott Medical | LCP | Class II | |
| K935615 | Medical Linear Accelerator | Accelerator Systems Intl., Inc. | IYE | Class II | |
| K933569 | Pent Nova Autoblock Syringe | Medi-Hut Co., Inc. | MEG | Class II | |
| K931921 | Corpak Gastrostomy Tube | Corpak Co. | KNT | Class II |