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 |
|---|---|---|---|---|---|
| K082798 | Digital Diagnostic X-Ray System, Models Mak 1500, Mak 2000 and Mak 3000 | Medicatech USA | KPR | Class II | |
| K082722 | P & F Power Wheelchair, Model Hc-500Sb | P & F Brother Ind., Corp. | ITI | Class II | |
| K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | Photo Medex, Inc. | GEX | Class II | |
| K082595 | Modification To:accu-Chek Pocket Compass Diabetes Management Software | Roche Diagnostics GmbH | LZG | Class II | |
| K082414 | Optiflux F250nr, Model 0500325E | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K082314 | Bravoracer Pediatric Manual Wheelchair | Otto Bock Healthcare LP | IOR | Class I | |
| K082209 | Devilbiss Dv5m Smartlink System | Sunrise Medical, Inc. | BZD | Class II | |
| K082183 | Pajunk's Generic Convenience Tray for Regional Anesthesia: Csf | Pajunk GmbH Medizintechnologie | CAZ | Class II | |
| K083043 | King`yield Wrist Blood Pressure Monitor, Model Bp201 | Shenzhen Kingyield Technology Co., Ltd | DXN | Class II | |
| K082919 | Uc-Care Positioning System | Uc-Care Medical Systems, Ltd. | EZL | Class II | |
| K082536 | Cook Wire Guides | Cook Incorporated | OCY | Class II | |
| K082464 | Prostiva RF Therapy Hand Piece, Model 8929 | Medtronic, Inc. | KNS | Class II | |
| K082164 | Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus: Single Shot | Pajunk GmbH Medizintechnologie | CAZ | Class II | |
| K081965 | Mpowrx Snoring Solution | Mpowrx Health and Wellness Products, Inc. | LRK | Class II | |
| K081733 | 10Mm X 40Mm Uncovered Wallflex Billiary Rx Stent System, Model M00570890 | Boston Scientific Corporation | FGE | Class II | |
| K081248 | Quanta Lite Omp Plus Elisa | Inova Diagnostics, Inc. | OKM | Class II | |
| K080339 | Medsource Endotracheal Tube (with and without Cuff) | Medsource International, LLC | BTR | Class II | |
| K072348 | Precision Oxygen Concentrator | Precision Medical, Inc. | CAW | Class II | |
| K083017 | Levo C3 | Levo AG | IPL | Class II | |
| K082923 | Prlong, Models Pl50, Pl100, Pl-40C, Pl-50C, Pl-100C, Pl-150C, Plt-40C, Plt-50C, Plt-100C, Plt-150C | Life-Tech, Inc. | CAC | Class II | |
| K082868 | Mullins-X, Model 250X | Numed Inc | DQY | Class II | |
| K082839 | Distal Radio-Ulnar Joint Implant | Aptis Medical, LLC. | KXE | Class II | |
| K082826 | Vanguard Cr Stem Housings | Biomet Manufacturing Corp | JWH | Class II | |
| K082597 | Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Linyuan Plastic Products Co., Ltd. | LYZ | Class I | |
| K082285 | Easy Glaze | Voco GmbH | EBD | Class II | |
| K082263 | Ceralas E 980Nm Diode Laser, Models E15/980 and E30/980 | Biolitec, Inc. | GEX | Class II | |
| K082120 | Aequalis Reversed Fracture Shoulder Prothesis | TORNIER Inc. | KWS | Class II | |
| K081900 | Temporary Tooth Replacement | Ormco Corp. | DZE | Class II | |
| K081732 | Innovance D-Dimer and Innovance D-Dimer Controls | Siemens Healthcare Diagnostics Inc. | DAP | Class II | |
| K081587 | Krell Weight & Body Fat Monitoring Scale, Model Bfa-8530 | Krell Precision (Yang Zhou) Co., Ltd. | MNW | Class II | |
| K081520 | Sensititre Vizion | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K081413 | Twinlotus and Shields Natural Rubber Latex Condom | Dailian Latex Company, Ltd. | HIS | Class II | |
| K082969 | Luminex Infrared Lamp System | Medical Laser Systems, Inc. | ILY | Class II | |
| K082865 | Modification to Zenieva | Gorbec Pharmaceutical Services, Inc. | NAE | Class I | |
| K082831 | Amself Closed Catheterization System | Amsino International, Inc. | FCM | Class II | |
| K082820 | K-Pack II Needle - 29G Thin Wall | Terumo Europe N.V. | FMI | Class II | |
| K082493 | Medical Display, Md205mg-1 | Nec Display Solutions, Ltd. | LLZ | Class II | |
| K082298 | Flash N' Go | Home Skinovations, Ltd. | GEX | Class II | |
| K082139 | Edwards Bovine Pericardial Patch, Model 4700 | Edwards Lifesciences LLC | DXZ | Class II | |
| K081650 | Aeroneb Go Nebulizer | Aerogen (Ireland), Ltd. | CAF | Class II | |
| K081543 | Vitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 5600 Integrated System | Ortho-Clinical Diagnostics, Inc. | JLW | Class II | |
| K081382 | Duckworth & Kent, Ltd., Implantation System, Model Dk7786 | Duckworth & Kent, Ltd. | KYB | Class I | |
| K081352 | Profile Multi-Platform System | Sciton, Inc. | GEX | Class II | |
| K080944 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard Inc | LJE | Unclassified | |
| K080003 | Binaxnow G6pd Test | Binax, Inc. | JBF | Class II | |
| K072603 | Abc Syringe Infusion Pump, Model 4100 | Elixir Corporation | FRN | Class II | |
| K083019 | Gemstar Sp Infusion System with Gemstar Sp Infusion Suite Software | Abbott Medical | FRN | Class II | |
| K083001 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K082822 | Powder-Free Vinyl Patient Examination Gloves | Zibo Zhuangyuan Plastic Products Company | LYZ | Class I | |
| K082812 | Omron Model Hbp-2070 Vital Signs Monitor | Omron Healthcare Co., Ltd. | MWI | Class II |