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 |
|---|---|---|---|---|---|
| K973025 | Fluid Centurion (4-100-00) | Northgate Technologies Inc. | FLN | Class II | |
| K972831 | Hemochron Citrate Aptt | Accriva Diagnostics, Inc. | GFO | Class II | |
| K972219 | Orthopedic Plate System | Ferguson Medical | HRS | Class II | |
| K972217 | Orthopedic Screw System | Ferguson Medical | HWC | Class II | |
| K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | GWF | Class II | |
| K971329 | Ctf Systems Inc, Whole-Cortex Meg System (with Optional EEG Subsystem) | Ctf Systems, Inc. | GWQ | Class II | |
| K970306 | Markman Template System | Barry Markman, M.D. | GAH | Class I | |
| K960552 | Knight Light Nonlubricated Condom | Global Protection Corp. | HIS | Class II | |
| K974190 | Cp&s Instant Cold Pack Limb Kit Transporter | Consolidated Products & Services, Inc. | IMD | Class I | |
| K973861 | Futura 67M, 68M, Megapowermp97, Integra 70,71,72,73, Supra 51,52, Supra 56,57,58,59, Suprema 45, 46, 47,48 | Magnatone Hearing Aid Corp. | ESD | Class I | |
| K973645 | Renegade Fiber Braided Microcatheter | Boston Scientific Corporation | KRA | Class II | |
| K973288 | Stabilor Hn | Degussa AG | EJS | Class II | |
| K973271 | Skar-Kare | Target Health, Inc. | MDA | Class I | |
| K973248 | Imtec Bone Collector System | Imtec Corp. | EHZ | Class I | |
| K973145 | Timesh Titanium Mini-Softplate and Micro-Soft Plate/screw System | Sofamor Danek USA,Inc. | JEY | Class II | |
| K972822 | Imation Se-204 Laser Imager | Imation Enterprises Corp. | LMC | Class II | |
| K972623 | Lmi Irrigation Catheter (Igr) | Lucas Medical, Inc. | DXE | Class II | |
| K972357 | Blue Max - 20 Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K972215 | Medimage | Vepro - Computersysteme GmbH | LLZ | Class II | |
| K971354 | Knott Ng Tube | Michael M. Knott, M.D. | FEG | Class II | |
| K970674 | G.e.m. Water Systems, International | G.E.M. Water Systems | FIN | Class II | |
| K970619 | Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle | Wilson Greatbatch Technologies, Inc. | CCW | Class I | |
| K973998 | Vinyl Patient Examination Gloves Powder-Free | Everrise Glove Products Co., Ltd. | LYZ | Class I | |
| K973934 | Sunglasses | Elegance Optical Manufactory Ltd. | HQY | Class I | |
| K973902 | Vinyl Patient Examination Gloves Powdered | Everrise Glove Products Co., Ltd. | LYZ | Class I | |
| K973656 | Disposable Silicone Epistaxis Catheter | Specialty Surgical Products, Inc. | EMX | Class I | |
| K973401 | Tempo 4 Angiography Catheter (Various) | Cordis US Corp. | DQO | Class II | |
| K973293 | Syntec True Light End Irrigating Endoilluminator | Vaughan Weeks | MPA | Class II | |
| K973180 | Imtec Bone Tac | Imtec Corp. | DZL | Class II | |
| K973128 | Olympus Na-10J-1 Aspiration Needle | OLYMPUS Corporation of the Americas | FOG | Class I | |
| K973121 | Interax Total Knee System | Howmedica Corp. | JWH | Class II | |
| K973085 | Ultracell Packing with Sleeve | Ultracell Medical Technologies, Inc. | EMX | Class I | |
| K972549 | Simpulse | KCI USA, Inc. | FNM | Class II | |
| K972539 | Hi Coat Powder Free Latex Patient Examination Gloves | P.T. Latexindo Tobaperkasa | LYY | Class I | |
| K972517 | Expert-Xl Orthopedic Hip Acquisition and Analysis Software | Lunar Corp. | KGI | Class II | |
| K971662 | Elvis Hsv Id/typing Test System | Ortho-Clinical Diagnostics, Inc. | GQN | Class II | |
| K970107 | Intubation Endoscope and Introducer Sheath | Urohealth Systems, Inc. | EOQ | Class II | |
| K955829 | Safpace System | B.Braun Medical, Inc. | LDF | Class II | |
| K973305 | Bact/alert Culture Bottles | bioMerieux, Inc. | MDB | Class I | |
| K973277 | Caroline Guide/delia Localizer | Surgical Solutions, LLC | HAW | Class II | |
| K973262 | Ketac-Fil Aplicap Plus | Espe GmbH & Co. KG. | EMA | Class II | |
| K973257 | Versaetch | Centrix, Inc. | EBF | Class II | |
| K973167 | Positive Pressure Connector | Abbott Medical | FPA | Class II | |
| K971889 | Chad Total O2 Delivery System | Chad Therapeutics, Inc. | CAW | Class II | |
| K971140 | Vital-Port Infusion Pal | Med Institute, Inc. | LJT | Class II | |
| K970938 | Hunter 0.014 Inch Super Soft / Hunter O.014 Inch Soft Guide Wires W/thromboresistant Pc Coating | Biocompatibles Cardiovascular, Inc. | DQX | Class II | |
| K970505 | Dade Pfa-100 Platelet Function Analyzer/pfa Collagen/epinephrine Test Cartridge/pfa Collagen/adp Test Cartridge/ | Dade Intl., Inc. | JOZ | Class II | |
| K970364 | Airtec2 Low Air Loss Therapy Bed | Apex Metal, Inc. | IOQ | Class II | |
| K970363 | Hydrotec Low Air Loss Therapy Bed | Apex Metal, Inc. | IOQ | Class II | |
| K973450 | Sensor Pad | Inventive Products, Inc. | IYO | Class II |