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 |
|---|---|---|---|---|---|
| K001029 | Geiger Needle Adapter, Model 406 | Geiger Medical Technologies, Inc. | GEI | Class II | |
| K001024 | Pass Spinal System | Encore Orthopedics, Inc. | MNH | Class II | |
| K000974 | Fowler Endocurette, Model Cur-Xxx | Utah Medical Products, Inc | HHK | Class II | |
| K000957 | Hoffmann II External Fixation System | Howmedica Osteonics Corp | LXT | Class II | |
| K000760 | Reach Femoral Component | Zimmer GmbH | LPH | Class II | |
| K000626 | Scandinavian Ivf Sciences Ab, Gamete-100 | Vitrolife AB/Scandinavian Ivf Sciences AB | MQL | Class II | |
| K000625 | Scandinavian Ivf Sciences Ab, G1.2 | Vitrolife AB/Scandinavian Ivf Sciences AB | MQL | Class II | |
| K000609 | Cardtel, Model Nt-100 | Cardiac Telecommunications | MWJ | Class II | |
| K000604 | Nature's Chemist Pain Relief Ointment and Therapeutic Ultrasound Coupling Agent | Naturopathic Laboratories International, Inc. | IMI | Class II | |
| K000178 | Nuzone Nitrile Surgical Gloves, Powdered, Green | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K000108 | Rapid Rhino-Anterior 90Mm, Model Rr-a 90, Rapid Rhino-Posterior 100Mm, Model Rr-P 100 | Bhk Holding | EMX | Class I | |
| K993586 | Sportsight Gp | Paragon Vision Sciences, Inc. | HQD | Class II | |
| K993319 | Vidas Toxo Igg II (Txg) Assay Model 30 210 | bioMerieux, Inc. | LGD | Class II | |
| K993131 | Nycocard Hba1c Glycosylated Hemoglobin Assay | Trinity Biotech (Primus Corporation dba Trinity Biotech) | LCP | Class II | |
| K000999 | Multisafe Powder-Free Patient Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) | Multisafe Sdn Bhd | LYY | Class I | |
| K000930 | Gatifloxacin Antimicrobial Susceptibility Test Disc | Oxoid, Ltd. | JTN | Class II | |
| K000880 | The Aptus (Automated Application of the Tpo Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the | Zeus Scientific LLC | LJM | Class II | |
| K000879 | The Aptus (Automated) Application of the Tg Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the | Zeus Scientific LLC | LJM | Class II | |
| K000596 | Etest Gatifloxacin | Ab Biodisk | JWY | Class II | |
| K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026a #Co5 | Agilent Technologies, Inc. | CBQ | Class II | |
| K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | JOW | Class II | |
| K001221 | Male Latex Comdom with Dotted Surface | Pleasure Latex Products Sdn. Bhd. | HIS | Class II | |
| K001119 | Rovers Endocervex-Brush | Rovers Medical Devices B.V. | HHT | Class II | |
| K001090 | Methafilcon a | CooperVision, Inc. | LPL | Class II | |
| K001089 | Polymacon | CooperVision, Inc. | LPL | Class II | |
| K001043 | Kawasumi Laboratory Blood Drawing Kit | Kawasumi Laboratories America, Inc. | KSB | Class II | |
| K000894 | C&b Resin Plus Powder/liquid, Models Retemp A2, A3, A3.5, Cl, Retemp B2, B3, C2, D3, Wh, Retemp Mo | Dental Ventures of America, Inc. | EBG | Class II | |
| K000849 | Softform Facial Implant | Tissue Technologies, Inc. | FTL | Class II | |
| K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8Fr 30Cc and 40Cc Universal | Arrow Intl., Inc. | DSP | Class II | |
| K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic) | Rochester Medical Corp. | KOD | Class II | |
| K000704 | Dmc Saphenous Vein Distention System (Svds) | DMC Medical Ltd. | GBX | Class I | |
| K000637 | Customcornea Measurement Device (Ccmd) | Alcon Laboratories | NCF | Class I | |
| K000308 | Wallstent Biliary Endoprosthesis | Boston Scientific Corporation | FGE | Class II | |
| K000233 | Menicon Sf-P | Menicon Co. Ltd. | HQD | Class II | |
| K000133 | Menicon Z | Menicon U.S.A., Inc. | HQD | Class II | |
| K994225 | Palomar Slp 2000 | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K993438 | Metal on Metal Acetabular System | Zimmer GmbH | KWA | Class III | |
| K992543 | Heartstream Xlt Defibrillator/monitor, Ac Charger, Dc Charger, Data Card, Single Bay Adapter, Defibrillator Pads Cable | Hewlett-Packard Co. | MKJ | Class III | |
| K992320 | Megabello Percutaneous Transluminal Angioplasty (Pta) Catheter | Boston Scientific Corporation | LIT | Class II | |
| K001451 | Modification to Depuy Contour Unicompartmental Knee Prosthesis | Depuy Orthopaedics Inc. | HRY | Class II | |
| K001335 | Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented | Exactech, Inc. | JDI | Class II | |
| K001257 | Intracoil Stent | Intratherapeutics, Inc. | JCT | Class II | |
| K001237 | Equinox Occlusion Balloon Catheter/system - (10Mm Balloon, 4 & 13 Mm Tip), (15 Mm Balloon, 4 & 13 Mm Tip), (20 Mm Balloo | Medtronic, Inc. | MJN | Class II | |
| K001098 | Pro.duct Health Micro-Stylet, Model Sty01 | Pro. Duct Health, Inc. | FMI | Class II | |
| K001086 | Free Testosterone Enzyme Immunoassay, Model Dsl-10-4900 | Diagnostic Systems Laboratories, Inc. | CDZ | Class I | |
| K000921 | Bayer Advia Ims System; 200 + 3 | Bayer Corp. | DER | Class II | |
| K000903 | Additional Assays for Bayer Advia Ims System | Bayer Corp. | KLT | Class II | |
| K000784 | The Cardiac Reader System | Roche Diagnostics GmbH | MMI | Class II | |
| K000779 | Apexpro Telemetry System | General Electric Medical Systems Information Techn | DSI | Class II | |
| K000611 | Steller Cd61 Assay for Use on the Imagn 2000 Microvolume Fluorimeter | Becton, Dickinson and Company, BD Biosciences | GKZ | Class II |