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 |
|---|---|---|---|---|---|
| K020480 | Rbm | Smith & Nephew, Inc. | KGS | Class I | |
| K020411 | Nuvasive Triad Facet Screw System | NuVasive Inc | MRW | Unclassified | |
| K020202 | Playtex Deodorant Tampons, Model 34702 | Playtex Products, Inc. | HIL | Class II | |
| K020201 | Playtex Deodorant Tampons, Model 34902 | Playtex Products, Inc. | HIL | Class II | |
| K014164 | Great Toe Implant System | Harmos Orthopaedics, Inc. | KWD | Class II | |
| K014109 | In-Time Retrieval Device | Boston Scientific Corporation | MMX | Class II | |
| K013109 | Sonopsy | Hakko Medical Co., Ltd. | FCG | Class II | |
| K012575 | Prefernce Imrt Treatment Planning Module | Northwest Medical Physics Equipment, Inc. | MUJ | Class II | |
| K012045 | Highgate Curved Rod System | Highgate Orthopaedics | KWQ | Class II | |
| K014090 | Endius Spinal Fixation System | Endius, Inc. | KWP | Class II | |
| K014000 | Vistitome 20-10 Microkeratome | Biovision, Inc. | HNO | Class I | |
| K012869 | Gimmi Alpha Hysteroscopes & Accessories, Models E.8xxx.xx, T.8xxx.xx, Zxxx.xx,s.xxxx.xx, K0142.25 | Gimmi GmbH | HIH | Class II | |
| K012377 | Oxford Modular Shoulder Prosthesis, 192.Xxx Catalogue Series | Corin USA | HSD | Class II | |
| K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | GEH | Class II | |
| K020594 | Diego Powered Dissector and Drill System | Gyrus Ent LLC | ERL | Class II | |
| K020472 | Biotech Manual Wheelchair B900 Super Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | IOR | Class I | |
| K020470 | Modification to Corlink Automated Anastomotic Device | Bypass, Ltd. | FZP | Class II | |
| K020438 | Sas Value Hcg | SA Scientific, Ltd | JHI | Class II | |
| K020403 | Modification to Ebi Xfix Dfs Optirom Elbow Fixator | Ebi, LLC | KTT | Class II | |
| K020391 | Stern Micro Era Attachment System | Sterngold | DZE | Class II | |
| K020265 | Serralene, Model Catalog No 1S | Serral, S.A. de C.V. | GAW | Class II | |
| K020188 | Biotech Manual Wheelchair, A1000 Super Sport Wheelchair | Taiwan Armada Enterprise Co., Ltd. | IOR | Class I | |
| K020100 | Sl 803, Sl 804, Sl 807, Sl 809, Sl 506, Sl 501, Sl 805 and Sl 801 Mechanical Wheelchairs | Regulatory Insight, Inc. | IOR | Class I | |
| K020094 | En 600-658, En 600-666, En 600-664, En 600-690, En 600-651, En 600-663, En 600-665 and En 600-670 Mechanical Wheelchairs | Regulatory Insight, Inc. | IOR | Class I | |
| K014286 | Salute, Model 3022 | Onux Medical, Inc. | GDW | Class II | |
| K014263 | Newgen/universal Mandibular System | Stryker Corp. | JEY | Class II | |
| K014072 | Fixion Unipolar Modular Hemi-Hip System (Fixion Uh) | Disc-O-Tech Medical Technologies, Ltd. | KWY | Class II | |
| K014057 | Dermastar Er:yag Laser System | Asclepion-Meditec AG | GEX | Class II | |
| K014054 | Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon Material | Edwards Lifesciences LLC | DQO | Class II | |
| K014053 | Conduit Tcp Granules | Depuyacromed | MQV | Class II | |
| K014052 | Edwards Lifesciences Percutaneous Sheath Introducers with Oligon Material | Edwards Lifesciences LLC | DYB | Class II | |
| K013677 | Modification to: Med-Ro Reverse Osmosis System | Usfilter/Ionpure, Inc. | FIP | Class II | |
| K013662 | Modification to Lipoprint System, Ldl Subfractions | Quantimetrix Corp. | JHO | Class I | |
| K013359 | Lp(a)-Latex Seiken Assay Kit | Denka Seiken'S | DFC | Class II | |
| K013318 | Actichrome Heparin (Anti-Fxa), Model 832 | Sekisui Diagnostics, LLC | KFF | Class II | |
| K013267 | Powder Free (Polymer Coated) Non Chlorinated White Latex Examination Gloves with Protein Content Labeling Claim (50 Mics | Siam Sempermed Corp., Ltd. | LYY | Class I | |
| K013005 | Act 11 Mp Ventricular Catheter | Innerspace, Inc. | HCA | Class II | |
| K012960 | Biogenex Monoclonal Anti-Progesterone Receptor | Biogenex Laboratories, Inc. | MXZ | Class II | |
| K020658 | Viatronix V3d Colon | Viatronix, Inc. | LLZ | Class II | |
| K020518 | Medela Symphony Breast Pump, Model 024 | Medela AG | HGX | Class II | |
| K020158 | Non-Eugenol Temporary Cement | J. Morita USA, Inc. | EMB | Class I | |
| K014075 | Bmc Coaxial Injectable Catheter, Model Cic 38/145 and Cic 35/145 | Baylis Medical Co., Inc. | DQX | Class II | |
| K014041 | Trufill Dcs Detachable Coil and Frufill Dcs Syringe, Also Known as the Trufill Dcs Detachable Coil System | Cordis Neurovascular, Inc. | HCG | Class II | |
| K014035 | Cooltouch and Cooltouch-II Nd:yag Laser Systems | Cooltouch Corp. | GEX | Class II | |
| K013168 | Imubind Plasma Pai-1 Elisa,model 822 | Sekisui Diagnostics, LLC | GGP | Class II | |
| K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) | Medtronic, Inc. | DQA | Class II | |
| K012506 | Mastergraft Resorbable Ceramic Granules | Medtronic Sofamor Danek USA Inc | MQV | Class II | |
| K020511 | Microscan Synergies Plus | Dade Microscan, Inc. | LON | Class II | |
| K020369 | Elecsys Anti-Tg Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K020359 | Ultra Touch Powdered Latex Examination Gloves | Ar Alliance Healthcare Sdn. Bhd. | LYY | Class I |