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 |
|---|---|---|---|---|---|
| K063663 | Dimension Vista Stfr Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H | Siemens Healthcare Diagnostics Inc. | DDG | Class II | |
| K063209 | Hba1c; Calibrator; Control Normal, Control Abnormal | Thermo Electron Oy | LCP | Class II | |
| K063186 | Athena Multi-Lyte Rubella Igg Test System | Zeus Scientific LLC | LFX | Class II | |
| K063128 | Advance Spiked Porous Tibial Base | Wrightmedicaltechnologyinc | MBH | Class II | |
| K063043 | Surgical Face Mask, Type: Tie-on, Ear-Loop | Modern Healthcare Corp. | FXX | Class II | |
| K062547 | Quadra Bloc TENS, Model 101 | Gradient Technologies, LLC | GZJ | Class II | |
| K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | GEX | Class II | |
| K070603 | C.t.m. Mobilitty Scooter # Hs-295 | C.T.M. Homecare Product, Inc. | INI | Class II | |
| K070588 | Philips Suresigns Vsv (Vital Signs Viewer) | Philips North America LLC | MHX | Class II | |
| K070532 | Spiros | Abbott Medical | FPA | Class II | |
| K070482 | Isis | Galil Medical Ltd. | GEH | Class II | |
| K070391 | Elecsys Pth Test System | Roche Diagnostics GmbH | CEW | Class II | |
| K070011 | Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter | Irvine Biomedical,Inc.(Ibi) | DQO | Class II | |
| K063863 | Advantage Cuff, Non-Invasive Blood Pressure Hose and Adapter | Advantage Medical Cables, Inc. | DXQ | Class II | |
| K063627 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K063556 | Peripatch Endo-Sleeve | Pm Devices, Inc. | FTM | Class II | |
| K063444 | Total Etch Bonding Agent | Dmg USA, Inc. | KLE | Class II | |
| K063403 | Conical Angled Abutment | ZimVie US Corp LLC | NHA | Class II | |
| K063347 | Axsym Anti-Ccp Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01 and 3L91-10 | Axis-Shield Diagnostics, Ltd. | NHX | Class II | |
| K062919 | Textured Powder Free Nitrile Exam Gloves (Peach) | Shen Wei (USA), Inc. | LZA | Class I | |
| K062873 | Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and Ihealth, Model 400 Stockings | E.C.I. USA Corporation | DWL | Class II | |
| K062308 | Lmt-Kath-S; Lmt-Kath-I | Licher Medizintechnologie GmbH | FPA | Class II | |
| K984207 | Silverlon Direct Pressure Wound Dressing | Argentum International, LLC | KMF | Class I | |
| K984205 | Silverlon Adhesive Strip | Argentum International, LLC | FRO | Unclassified | |
| K984204 | Silverlon Direct Pressure Wound Closure Strip | Argentum International, LLC | FRO | Unclassified | |
| K070420 | Bioshield-Ercp Biopsy Valve, Model 00711138 | United States Endoscopy Group, Inc. | ODD | Class II | |
| K070342 | Clinical Electronic Thermometer, Models Tp11403 Through Tp11413 | American I.V. Products, Inc. | FLL | Class II | |
| K070200 | Tdm Control Set, Model Cat# 04521536 | Roche Diagnostics GmbH | JJY | Class I | |
| K070188 | Powder Free Vinyl Patient Examination Glove, Yellow | Hong di Plastic Products Co., Ltd. | LYZ | Class I | |
| K070033 | Memometal Varisation, Models Av26-08, Av26-10, Av90-08 and Av90-10 | Memometal Technologies | JDR | Class II | |
| K070031 | Memometal Memory Staples | Memometal Technologies | JDR | Class II | |
| K063866 | Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories Inc. | LIP | Class II | |
| K063756 | Dimension Vista Ctni Flex Reagent Cartridge | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control | Thermo Electron Oy | CZW | Class II | |
| K062621 | Nio 5Mp-21 and Mdng-5121 Cb | Barco N.V. | LLZ | Class II | |
| K061504 | Powder Free Nitrile Blue Examination Glove | Liwe Trading | LZA | Class I | |
| K060648 | Reprocessed Phacoemulsification Tips | Alliance Medical Corp. | NKX | Class II | |
| K070563 | Vidar Vision 2000 | Vidar Systems Corp. | MQB | Class II | |
| K070487 | Smartwire Pressure Guide Wire, Model 66Xx | Volcano Corporation | DXO | Class II | |
| K070464 | Ondemand3d | Cybermed Inc. | LLZ | Class II | |
| K070442 | Powerled Surgical Light System | Maquet Cardiovascular Us Sales, LLC | FSY | Class II | |
| K070440 | Bd Hypoint Needle | Becton Dickinson & Co | FMI | Class II | |
| K070436 | Biomarc Gold Tissue Marker | Carbon Medical Technologies, Inc. | NEU | Class II | |
| K070433 | Lerado, Power Wheelchair, Pb | Lerado China Limited | ITI | Class II | |
| K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions LLC | GEX | Class II | |
| K070214 | Gender Solutions Natural-Knee Flex System | Zimmer GmbH | MBH | Class II | |
| K063432 | Conformis Metal Backed Tibial Component(mbt) | ConforMIS, Inc. | HSX | Class II | |
| K063384 | Diodent Micro Dental Laser System, Models 810 and 980 | Hoya Conbio, Inc. | GEX | Class II | |
| K063316 | Fujinon Model Eg-530N Trans Nasal Insertion | FUJIFILM Healthcare Americas Corporation | FDS | Class II | |
| K062976 | Modification to Cic Pro Clinical Information Center | GE Medical Systems Information Technologies, Inc. | DSI | Class II |