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 |
|---|---|---|---|---|---|
| K063867 | Cutera Er:ysgg Laser Handpiece | Cutera Inc | GEX | Class II | |
| K063155 | Monarch III IOL Delivery System | Alcon Manufacturing, Ltd. | KYB | Class I | |
| K063090 | Medrad Stellant CT Injector System with Xds Accessory | Medrad, Inc. | IZQ | Class II | |
| K060976 | Moorld12-B1 Laser Doppler Burns Imager | Moor Instruments Ltd. | DPT | Class II | |
| K070629 | Flex and Loop Coil Set 1.5 T | Siemens Medical Solutions | MOS | Class II | |
| K070576 | Acuson X150 Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K070476 | Revolix 120 | Allmed Systems, Inc. | GEX | Class II | |
| K070407 | Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow, White, and Blue | Dukal Corp. | FXX | Class II | |
| K070404 | Nitrile Powder Free Patient Examination Gloves | Tangshan Luxiong Plastic Products Co., Ltd. | LZA | Class I | |
| K070169 | Kls Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS-Martin L.P. | HRS | Class II | |
| K070045 | Zirblank-Ps and Zirblank-Fs | Acucera, Inc. | EIH | Class II | |
| K063864 | Qwikcheck Test Strips- Reagent Strips for Semen Analysis | Medical Electronic Systems Ltd. | POV | Class II | |
| K063770 | Alpha-Bio Orthodontic Fixation Screw System | Alpha-Bio Tec | OAT | Class II | |
| K063442 | All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor | Degania Silicone, Inc. | EZL | Class II | |
| K063401 | Banana Ribbed | MedTech Products, Inc. | HIS | Class II | |
| K070545 | K-Y Brand Warming Liquid | Personal Products Co. | NUC | Class II | |
| K070542 | Cardius 1, 2 and 3 Xpo and 2020Tc Spect Imaging Systems | Digirad Corp. | KPS | Class II | |
| K070526 | Dp-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYO | Class II | |
| K070493 | Heartway Power Tilt Seating System Power Chair, P17rt | Heartway Medical Products Co., Ltd. | INI | Class II | |
| K070468 | Implant Sciences Corp. Model Hdr 4454 | Implant Sciences Corp. | KXK | Class II | |
| K070205 | Ziostation | Ziosoft, Inc. | LLZ | Class II | |
| K070204 | Link to Acuity Clinician Notifier | Welch Allyn Protocol, Inc. | MSX | Class II | |
| K070142 | Slendertone System ABS, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K070097 | Powder Free Nitrile Examination Gloves, Peppermint Scented, Blue Color | Gx Corporation Sdn Bhd | LZA | Class I | |
| K070038 | Powder Free Vinyl Patient Examination Glove, Yellow | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | |
| K063804 | Olympus Triglyceride Test System | OLYMPUS Corporation of the Americas | CDT | Class I | |
| K063356 | Stratus Cs Acute Care D-Dimer Testpak, Dilpak, Calpak | Siemens Healthcare Diagnostics Inc. | DAP | Class II | |
| K063324 | Pet Vcar | GE Healthcare | JAK | Class II | |
| K063293 | Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards Aquaspike and Aquasafe | Edwards Lifesciences Services GmbH | FJK | Class II | |
| K063044 | Cardiobelt Electrode Belt | Monebo Technologies, Inc. | DRX | Class II | |
| K063005 | Stryker T6 Hoods and Togas | Stryker Corp. | FYA | Class II | |
| K062033 | Bp 101 Digital Blood Pressure Monitor | Kingyield Hongkong Limited | DXN | Class II | |
| K061412 | Thermo Electron Enzymatic Creatinine, Model Tr35401 | Thermo Electron Oy | JFY | Class II | |
| K070509 | Fisso Holding System | Baitella AG | GCJ | Class II | |
| K070501 | Ruike 3421 Powered Wheelchair | Shanghai Ruike Sports Goods Co., Ltd. | ITI | Class II | |
| K070485 | Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L | Cardiva Medical, Inc. | DXC | Class II | |
| K070306 | Paint- on Polish Agent | Dentsply International, Inc. | EBD | Class II | |
| K070134 | Modification to Stimuplex Hns-12, Model 4892098 | Stockert GmbH | BXN | Class II | |
| K070027 | Powdered (White) Vinyl Patient Examination | Shijiazhuang Lianhe Shunda Plastic Products Co., L | LYZ | Class I | |
| K063599 | Porti 7 Physiological Amplifier | Tms International BV | GWL | Class II | |
| K063568 | Hwato Tdp Heat Lamp, Models Tdp11-Dl, Tdp12-Xl and Tdp-22Xl | Suzhou Medical Appliance Factory | ILY | Class II | |
| K063430 | Zero Profile Anterior Cervical Plate (Acp) System | Howmedica Osteonics Corp | KWQ | Class II | |
| K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | Richard Wolf Medical Instruments Corp. | FJL | Class II | |
| K062282 | Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | DPS | Class II | |
| K062014 | Families of Master Neb, Primo Neb, Sc03, Neb Aid, 4.2.Neb, Q03, Fj03, and Walkie-Neb | Flaem Nuova S.p.A. | CAF | Class II | |
| K070325 | Clearfil Majesty Esthetic Plt | Kuraray Medical, Inc. | EBF | Class II | |
| K070213 | Performer Cbp System | Rand S.r.l. | DTQ | Class II | |
| K070100 | Haselmeier Pen | Haselmeier SARL | FMF | Class II | |
| K070073 | Align Urethral Support System | C.R. Bard Inc | OTN | Class II | |
| K070039 | Memometal Fixos Screws | Memometal Technologies | HWC | Class II |