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 |
|---|---|---|---|---|---|
| K021598 | Elastylite Synthetic Powdered Surgical Glove | Eci Medical Technologies, Inc. | KGO | Class I | |
| K021536 | Dermagrip and Multiple Powder Free Latex Examination Gloves, Non-Sterile with Protein Content Labeling Claim (50 Microgr | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | |
| K021388 | Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination Gloves Contains 50 Mcgm or Less of Total Water Extram | Seal Polymer Industries Bhd. | LYY | Class I | |
| K021381 | Modification to N/t Rheumatology Controls Sl 1 & 2 | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K021020 | Terumo Gas Filter | Terumo Cardiovascular Systems Corporation | CAH | Class II | |
| K021006 | Startox Drug of Abuse Screening Test | Starplex Scientific Corp. | DKZ | Class II | |
| K020880 | Marknew Products Acupuncture Needles | Marknew Products | MQX | Class II | |
| K020803 | Cefar Medical Ab Cefar Primo | Cefar Medical AB | GZJ | Class II | |
| K020800 | Optax System | Optax Systems, Inc. | LQD | Unclassified | |
| K020297 | Stat Profile Critical Care Xpress Analyzer | Nova Biomedical Corporation | CHL | Class II | |
| K014069 | Lifesign Coc, Status Stik Coc, Accusign Stik Coc, Accustik Coc | Princeton BioMeditech Corp. | DIO | Class II | |
| K014067 | Lifesign Cocaine, Marijuana (Thc), Lifesign Doa2 (Thc/coc), Status Stik Thc/coc, Accusign Stik Thc/coc, Accustik Thc/coc | Princeton BioMeditech Corp. | DIO | Class II | |
| K014066 | Lifesign Thc, Status Stik Thc, Accusign Stik Thc, Lifesign Marijuana, Accustik Thc | Princeton BioMeditech Corp. | LDJ | Class II | |
| K010952 | Surgisis Guided Tissue Regeneration Matrix | Cook Biotech, Inc. | NPL | Class II | |
| K021527 | Sectra Osteoporosis Package | Sectra-Imtec AB | KGI | Class II | |
| K021427 | Clearfil Sa Primer | Kuraray Medical, Inc. | KLE | Class II | |
| K021412 | Latex Examination Gloves, Powder Free, Polymer Coated | Arista Latindo Industrial, Ltd. P.T. | LYY | Class I | |
| K021378 | Portable Hdx Intraoral X-Ray | Dentalez Group | EHD | Class II | |
| K021372 | Veraviewepocs Panoramic X-Ray Unit with Cephalometric Capability | J. Morita USA, Inc. | EAG | Class II | |
| K020783 | Telesis Digital Infrared Thermal Image System, Spectrum 9000Mb | Telesis Technologies, Inc. | LHQ | Class I | |
| K014088 | Duploreach | Baxter Healthcare Corporation | FMF | Class II | |
| K012232 | Insight, Model S980000 | Diversatek Healthcare Inc | FFX | Class II | |
| K021704 | Vaxcel Picc with Pasv Valve Technology | Catheter Innovations, Inc. | LJS | Class II | |
| K021519 | Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, Wands | ArthroCare Corporation | GEI | Class II | |
| K021518 | Paindoc | Abbott Medical | GZB | Class II | |
| K021506 | Powdered (Blue) Nitrile Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | LZA | Class I | |
| K021502 | Oscar, Model Oe3000 | Orthosonics, Ltd. | LZV | Class II | |
| K021494 | Gdc Power Supply, Model Gdc Power Supply: 451007-4 | Boston Scientific Corporation | HCG | Class II | |
| K021463 | Model 1133 IVD Pc Version | Sun Nuclear Corporation | IYE | Class II | |
| K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,iab5840 | Arrow Intl., Inc. | DSP | Class II | |
| K021445 | Etest Cefditoren for S. Pneumoniae and H. Influenzae | Ab Biodisk | JWY | Class II | |
| K021353 | Powder-Free-Vinyl Examination Gloves, Color: White | Glormed Intl., Inc. | LYZ | Class I | |
| K021220 | Nitrile Patient Examination Glove Powder-Free (Blue Color) Tested for Use with Chemotherapy Drugs | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K021188 | Microscan Microstrep Plus Panel New Antimicrobial-Cefepime | Dade Microscan, Inc. | JWY | Class II | |
| K021169 | Microstrep Plus Panel, Azithromycin | Dade Microscan, Inc. | JWY | Class II | |
| K021111 | Microscan Microstrep Plus Panel New Antimicrobial - Cefotaxime | Dade Microscan, Inc. | LTT | Class II | |
| K021110 | Microscan Microstrep Plus Panel New Antimicrobial- Ceftriaxone | Dade Microscan, Inc. | JWY | Class II | |
| K021078 | Microscan Microstrep Plus Panel New Antimicrobial-Erythromycin | Dade Microscan, Inc. | LTT | Class II | |
| K021072 | Filmsaver, Nt Version 5.03 | American Medical Resources, Ltd. (Amr) | LLZ | Class II | |
| K021021 | Modular Angiography System Axiom Artis | Siemens Medical Solutions USA, Inc. | JAA | Class II | |
| K021010 | Modified Cardiac Cryosurgical System, Models 6Tcs1 & 6Tcse | Varian Medical Systems, Inc. | OCL | Class II | |
| K021004 | Valved Peelable Introducer | Greatbatch Medical | DYB | Class II | |
| K020971 | Dcm 2.0 | Mds Nordion | MUJ | Class II | |
| K020943 | Sterile Disposable Vinyl Exam Gloves, Powder Free | Shanghai Antares Industries, Inc. | LYZ | Class I | |
| K020860 | M3 (Micro-Multileaf Collimator) | Brainlab, Inc. | IYE | Class II | |
| K020850 | Gpf-29 General Purpose Coil Set | Mri Devices Corp. | MOS | Class II | |
| K020830 | Scorpio Inset Patellar Component | Howmedica Osteonics Corp | JWH | Class II | |
| K020791 | Hbs Headless Bone Screw | Millennium Medical Technologies, Inc. | HWC | Class II | |
| K013980 | Safe Shield Pre-Powdered Latex Examination Gloves | Safe Shield Co., Ltd. | LYY | Class I | |
| K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | Hyperbaric Technologies, Inc. | CBF | Class II |