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 |
|---|---|---|---|---|---|
| K101564 | Cdc Influenza 2009 A(h1n1)pdm Real-Time Rt-PCR Panel | Centers for Disease Control and Prevention | OQW | Class II | |
| K101451 | Apex Module Hip System Biolox Delta Femoral Head | Omni Life Science, Inc. | LZO | Class II | |
| K101430 | Mls-Ac Derma Scanner | Erchonia Corporation | NHN | Class II | |
| K101385 | Dual Luer Lock Cap, Model 2C6250 | Baxter Healthcare Corporation | FPA | Class II | |
| K101345 | Webster Cs Catheter with Ez Steer Technology, Webster Cs Catheter with Ez Steer Technology and Auto Id Model: D-1263-04, | Biosense Webster Inc | DRF | Class II | |
| K101138 | Soundstar 3D Ultrasound Catheter Model M-5723-12 | Biosense Webster Inc | OBJ | Class II | |
| K101137 | Powder Free Vinyl Patient Examination Glove | Hongze Plastic Technology Co., Ltd. | LYZ | Class I | |
| K101074 | Modification to: Cd Horizon(r) Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K100908 | Unicem Hm | 3M Espe AG Dental Products | EMA | Class II | |
| K100631 | Affiity Cp Centrifugal Blood Pump | Medtronic, Inc. | KFM | Class II | |
| K100538 | Tina-Quant Ferritin Gen. 4 | Roche Diagnostics GmbH | DBF | Class II | |
| K100495 | Philips Avent Digital Thermometer Set, Model Sch540 | Philips Electronics UK Limited | FLL | Class II | |
| K100388 | 21St Century Centurion Exceled and System Two LED Lighting Systems | Medical Illumination International, Inc | FST | Class II | |
| K093955 | Anti-Hav Igm | Roche Diagnostics GmbH | LOL | Class II | |
| K093407 | Zquiet Mouthpiece | Sleeping Well, LLC | LRK | Class II | |
| K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co. KG | GEI | Class II | |
| K092874 | Powder Free Nitrile (Dark Blue) Examination Gloves | Quality Gallant Sdn. Bhd. | LZA | Class I | |
| K090081 | Talladium International Implantology Abutments | Talladium Espana, SL | NHA | Class II | |
| K101448 | Opus Speedscrew System | ArthroCare Corporation | MBI | Class II | |
| K101080 | Non Stick Bipolar Forceps Model 07/Xxx, Bipolar Forceps Model 08/Xxx, Monopolar Forceps Model 09/Xxx | Egon Faulhaber Surgical Instruments Pinzetten | GEI | Class II | |
| K100781 | Obsidian Ceramic Blocks | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K100497 | Quantum Im Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | HSB | Class II | |
| K100333 | Fiab Spa, Models F7244, F7233, F7234, F7277 | Fiab SpA | GEI | Class II | |
| K101475 | Compress Anti-Rotation Spindles | Biomet Manufacturing Corp | KWA | Class III | |
| K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | MHX | Class II | |
| K101440 | Gmd Universal Urinary Incontinence Sling, Model 1012 | Generic Medical Devices, Inc. | OTN | Class II | |
| K101115 | Eli 150 Electrocardiograph Model Eli 150 | Mortara Instrument, Inc. | DPS | Class II | |
| K101111 | Halo Ablation Catheter Model 90-9100, Halo90 Ultra Ablation Catheter Model 90-9200 | Medtronic, Inc. | GEI | Class II | |
| K100900 | Motivation Knee System | Encore Medical, LP | JWH | Class II | |
| K100801 | Puma Model Version 1.0 | Prowess, Inc. | IYE | Class II | |
| K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | KWP | Class II | |
| K100638 | Vapr Vue Radiofrequency System ,Model 225024, Vpr Vue Wireless Footswitch, Model 227214 | DePuy Mitek, Inc. | GEI | Class II | |
| K100501 | Multifunctional Linear Pen | AtriCure, Inc. | OCL | Class II | |
| K093810 | Bf-Navi | Kgt, Inc. | JAK | Class II | |
| K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem Cvp 2 (Addition of Total Bilirubim Assignment to | Instrumentation Laboratory Co. | CIG | Class II | |
| K093566 | Carto Xp Ep Navigation System, Version 10 | Biosense Webster Inc | DQK | Class II | |
| K093376 | Lasso Nav Catheter | Biosense Webster Inc | DRF | Class II | |
| K093335 | Laglove Brand Nitrile Examination Gloves, Powder Free, Non-Sterile (Pink Color) | La Glove (M) Sdn. Bhd. | LZA | Class I | |
| K093320 | Dryodine Cadexomer-Iodine Gel | Collegium Pharmaceutical Incorporated | FRO | Unclassified | |
| K093109 | Novotwist Needle, Models 30G * 8Mm (1/3) 32 G Tip * 5 Mm(1/5') | Novo Nordisk a/S | FMI | Class II | |
| K092938 | Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710 | Fresenius Kabi USA, LLC | NZW | Class II | |
| K092052 | Rightest Blood Glucose Monitoring System, Model Gm550 | Bionime Corporation | NBW | Class II | |
| K091786 | Pulsion Picco2 (8500), Cevox Optical Module (Pc3015), Cevox Disposable Probes (Pv2022-30 Thru -38, Pv2022-46 Thru -48) | Pulsion Medical Systems AG | DXG | Class II | |
| K101523 | Circuflow 5200 Sequential Compression Device | Devon Medical, Inc. | JOW | Class II | |
| K101438 | T2 Greater Trochanter Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K101399 | Coaxial Introducer Set | Martech Medical Products | DYB | Class II | |
| K101362 | Powder-Free Vinyl Patient Examination Gloves, Colored (Yellow) | Hebei Handform Plastic Products Co., Ltd. | LYZ | Class I | |
| K101259 | V-Trust Td-8002 Multi-Parameter Spot-Check Monitor Model Td-8002 | Taidoc Technology Corporation | MWI | Class II | |
| K101218 | Patchassist | Polytouch Medical, Ltd. | ORQ | Class II | |
| K101131 | Fiducial Markers | Boston Scientific Neuromodulation Corporation | IYE | Class II |