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 |
|---|---|---|---|---|---|
| K092488 | Dynarex Sterile Lubricating Jelly | Dynarex Corp. | KMJ | Class I | |
| K092483 | Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018 | C.R. Bard Inc | GDW | Class II | |
| K092044 | Orthocor Knee System, Median, Large, X-Large | Orthocor Medical Inc. | ILX | Class II | |
| K091045 | Smart TENS, Model: D-Bc05t | Body Clock Health Care Ltd | GZJ | Class II | |
| K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Beiersdorf, Inc. | DWL | Class II | |
| K090806 | Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact Lens, Safi-Gel Daily Disposable Toric ( Methafilcon | Safilens S.r.l. | LPL | Class II | |
| K090533 | Hlm Tubing Set with Softline Coating | MAQUET CARDIOPULMONARY GmbH | DWF | Class II | |
| K090518 | Quart Arterial Filter with Softline Coating | MAQUET CARDIOPULMONARY GmbH | DTM | Class II | |
| K090515 | Rotaflow Centrifugal Pump with Softline Coating, Model Bo-RF-32 (USA) | MAQUET CARDIOPULMONARY GmbH | KFM | Class II | |
| K093646 | Depuy Pinnacle with Gription Acetabular Cups | Depuy Orthopaedics Inc. | JDI | Class II | |
| K093546 | Supercath 5 Model Sp120-Xx-Xx, Sp125-Xx-Xx | Togo Medikit Co., Ltd. | FOZ | Class II | |
| K093428 | Smith & Nephew Knotless Instability Anchor | Smith & Nephew Endoscopy, Inc. | MBI | Class II | |
| K093397 | Traxcess 14Ex Guidewire and Traxcess Docking Wire | Terumo Cardiovascular Systems Corporation | DQX | Class II | |
| K093259 | Arp Rx100 | Arp Manufacturing, Inc. | IPF | Class II | |
| K093252 | Footprint Medical Peripherally Inserted Central Catheter | Footprint Medical Inc. | LJS | Class II | |
| K093090 | Galileos Implant, Version 1.7 | Sicat GmbH & Co. KG | LLZ | Class II | |
| K092953 | Xpert VanA Assay | Cepheid | NIJ | Class II | |
| K092557 | Digital Thermometer,hmcdt-002/Kinetik Branded Dt1 Series | Harvard Medical Devices, Ltd. | FLL | Class II | |
| K092344 | Lac-Mac Innerbloc Lr Surgical Gowns | Lac-Mac Limited | FYA | Class II | |
| K092264 | Atlantis Hyperbaric Chamber Ventilator | Providence Global Medical, Inc. | CBK | Class II | |
| K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | DXH | Class II | |
| K093549 | 44Mm E1 Acetabular Liner with 44Mm Biolox Delta Option Ceramic Head or 44Mm M a Magnum | Biomet Manufacturing Corp | LZO | Class II | |
| K093534 | Modification to Caspian Spinal System | K2M, Inc | KWP | Class II | |
| K093513 | Iduo Bicompartmental Knee Repair System | ConforMIS, Inc. | NPJ | Class II | |
| K093260 | Aeronox Nitric Oxide Titration & Monitoring System | International Biomedical, Ltd. | MRN | Class II | |
| K093144 | Lousebuster | Larada Sciences Inc. | LJL | Class I | |
| K093084 | Rolence Dental High Speed Handpiece, Rhp | Rolence Ent. Inc. | EFB | Class I | |
| K092928 | Dose Volume Histogram (Dvh) Evaluator | Diversilabs | MUJ | Class II | |
| K092912 | Starfill 2B Hv (High Viscosity) Rockcore, Model: 90838 and Starfill 2B Lv (Low Viscosity), Model: 90150 | Danville Materials, Inc. | EBF | Class II | |
| K092445 | Sensititre 18-24 Hour Susceptibility Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K092236 | E.coli/p. Aeruginosa Pna Fish | Advandx, Inc. | JSS | Class I | |
| K092169 | Elecsys Probnp II Calcheck 5 | Roche Diagnostics GmbH | JJX | Class I | |
| K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics Inc. | LIP | Class II | |
| K091118 | Foot and Hand Motion System | Newclip Technics | HWC | Class II | |
| K091034 | Aquacel Ag Surgical | ConvaTec Limited | FRO | Unclassified | |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models Is1200, Is2000 and Is3000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K090964 | Binaxnox Staphylococcus Aureus Test | Binax, Inc. | JWX | Class I | |
| K093665 | Endo Smartcap | Byrne Medical, Inc. | FAJ | Class II | |
| K093583 | Ep -Nursemate, Ep -Nursemate with Physio Module | Abbott Medical | DQK | Class II | |
| K093527 | Aria Radiation Oncology with Mirs | Varian Medical Systems, Inc. | IYE | Class II | |
| K093346 | Bd Geneohm Mrsa Acp Assay | BD Diagnostics (Geneohm Sciences, Inc.) | NQX | Class II | |
| K093228 | Smith & Nephew Twinfix Ultra Pk Suture Anchor | Smith & Nephew, Inc. | MBI | Class II | |
| K093164 | 3.25 Spline Twist Implant, Ha Coated | ZimVie US Corp LLC | DZE | Class II | |
| K093163 | Integra Total Wrist Fusion System | Integra LifeSciences Corporation | HRS | Class II | |
| K093056 | Smith & Nephew, Inc. Journey Select Knee System | Smith & Nephew, Inc. | NPJ | Class II | |
| K092850 | Endoflip | Crospon, Ltd. | FFX | Class II | |
| K092814 | Straumann Dental Abutments | Straumann USA, LLC | NHA | Class II | |
| K092550 | Tigrt Ivs | Linatech, LLC | IYE | Class II | |
| K092548 | Extremity Medical Trapezium Prosthesis | Extremity Medical, LLC | KYI | Class II | |
| K092325 | Modification To:cd Horizon Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II |