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 |
|---|---|---|---|---|---|
| K090194 | Powder- Free Nitrile Examination Gloves, Black Color | Shen Wei (USA), Inc. | LZA | Class I | |
| K083658 | Pacs Plus 5Th Edition | Medical Standard Co., Ltd. | LLZ | Class II | |
| K083094 | Streamer Polymer Guidewire | Brivant, Ltd. | DQX | Class II | |
| K091727 | Medical Treatment Chair, T400, T500,t600 | Fresenius Medical Care South Asia Pacific Pty, Ltd. | INO | Class II | |
| K091723 | Freedom Sciences Motion Control Module Version 1.5 | Freedom Sciences, LLC | ITI | Class II | |
| K091482 | Huayi K-Series Lightweight Wheelchair K3/k4 | Danyang Huayi Medical Supply & Equipment Co, Ltd | IOR | Class I | |
| K091418 | C.t.m. Mobility Scooter, Model Hs-628, Invacare Orion | C.T.M. Homecare Product, Inc. | INI | Class II | |
| K091242 | Bantam | Altimate Medical, Inc. | INO | Class II | |
| K090901 | Esensor Cf Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models Xt-8 | Osmetech Molecular Diagnostics | NUA | Class II | |
| K090792 | Mitaka Uniarm | Mitaka Kohki Co., Ltd. | GCJ | Class II | |
| K090735 | C.t.m. Mobility Scooter, Hs-528 | C.T.M. Homecare Product, Inc. | INI | Class II | |
| K090434 | Bece Press | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & Co | EIH | Class II | |
| K090256 | Power Standing Dani | Davismade, Inc. | IPL | Class II | |
| K091854 | Bis Click Sensor/cable | Aspect Medical Systems, Inc. | GXY | Class II | |
| K091683 | Kowa Vx-10 a | Kowa Co., Ltd. | HKI | Class II | |
| K091627 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | KCT | Class II | |
| K091596 | Evalve Steerable Guide Catheter, Model Sgc01st | Evalve, Inc. | DRA | Class II | |
| K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | JAQ | Class II | |
| K091377 | Bd Flu+ Syringe | Becton Dickinson & Co | FMF | Class II | |
| K091304 | Vortex Cannula | Vortex Medical, Inc. | DWF | Class II | |
| K091007 | Air Purge Control System for S5 System Model 23-45-05 | LivaNova Deutschland GmbH | DTQ | Class II | |
| K090981 | Modification to: Nuvasive Spherx System | NuVasive Inc | NKB | Class II | |
| K090851 | Defendo (Tm) Biopsy Valve for Olympus(r) and Fujinon(r) Endoscopes, Model 100301, Defendo(tm) Biopsy Valve for Pentax(r) | Byrne Medical, Inc. | ODC | Class II | |
| K090582 | Calcaneal Fracture Plate System | TORNIER Inc. | HRS | Class II | |
| K090554 | Acuity Mailman and Strait-Trak Guidewire | Boston Scientific Corporation | DQX | Class II | |
| K090541 | Elecsys Precicontrol Universal | Roche Diagnostics GmbH | JJY | Class I | |
| K090522 | Osteomed Hand Plate and Screw Fixation System | Osteomed | HRS | Class II | |
| K083896 | Destiny Max Coagulation Analyzer | Trinity Biotech, PLC | JPA | Class II | |
| K083686 | Baixin Disposable Syringe, Multiple Sizes | Anhui Kangda Medical Products Co., Ltd. | FMF | Class II | |
| K083004 | Mili (Minimally Invasive Lumbar Implant) System | Aesculap Inc | NKB | Class II | |
| K091881 | Rpl/cpl Vertical Platform Lifts | Harmar Summit, LLC | ING | Class II | |
| K091858 | Pinnacle Stair Way Lift | Summit Harmar, LLC | ILK | Class II | |
| K091855 | The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model Fms2000 | Belmont Medical Technologies | FRN | Class II | |
| K091816 | Ultraflex Esophageal Ng Stent System | Boston Scientific Corporation | ESW | Class II | |
| K091747 | Flaatz 500 | DRTECH Corporation | KPR | Class II | |
| K091670 | Bd L-Cath Single and Dual Lument Catheters, Midline Catheter | Becton Dickinson & Co | LJS | Class II | |
| K091587 | Mercury Spinal System | Spinal Elements, Inc | NKB | Class II | |
| K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | DQY | Class II | |
| K090983 | Aptus 2.0/2.3 Four Corner Fusion Plate | Medartis AG | HRS | Class II | |
| K090935 | Minime Pediatric Mask | SleepNet Corporation | BZD | Class II | |
| K090847 | Platelia Toxo Igm Kit Model 26211 | Bio-Rad Laboratories Inc. | LGD | Class II | |
| K090613 | Cps Aim Sl Slittable Inner Catheters, Models Ds2n021-59, Ds2n022-59, Ds2no23-59, Ds2n024-65, Ds2n024-65, Ds2n021-65, Ds2 | St. Jude Medical, Cardiac Rhythm Management Divisi | DQY | Class II | |
| K090523 | Polaris Spinal System | Ebi, LLC | NKB | Class II | |
| K090336 | Sunmax Enterprise Shanghai Co. Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs | Sunmax Enterprise Shanghai Co., Ltd. | LZA | Class I | |
| K090221 | Reaction System | Viora, Ltd. | NUV | Class II | |
| K090211 | Inflatable Bone Tamp | Medtronic, Inc. | NDN | Class II | |
| K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | FRN | Class II | |
| K082629 | S12x with Esax Option | Chatten Associates, Inc. | GYC | Class II | |
| K081923 | Actiprotect Uf N95 Respirator, Double Strap, Flat Fold | Glaxosmithkline Consumer Healthcare | ONT | Class II | |
| K091641 | Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft) | Terumo Cardiovascular Systems Corporation | HCG | Class II |