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 |
|---|---|---|---|---|---|
| K083271 | Bsm-2300 &Bsm6000 with Cgs-9001 Series Communication Gateway, Model Cgs-9001 Series Optional Accessory | Nihon Kohden America Inc | MHX | Class II | |
| K083232 | Modification To:microfuse Bone Void Filler | Globus Medical, Inc. | MQV | Class II | |
| K083091 | Lc Bead Microspheres, Bead Block Compressible Microspheres | BIOCOMPATIBLES U.K. Limited, a BTG Company | KRD | Class II | |
| K082020 | Envision Blood Glucose Test System | Infopia Co, Ltd. | NBW | Class II | |
| K081551 | Twin Neurotrac-III | Astro-Med, Inc. | OMA | Class II | |
| K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5 | Core Essence Orthopaedics, LLC | GAQ | Class II | |
| K083638 | Fixation Trocars | Applied Medical Resources Corp | GCJ | Class II | |
| K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Inc. | GEX | Class II | |
| K083576 | Miser Contrast Management System | Merit Medical Systems, Inc. | FPA | Class II | |
| K083474 | Zimmer Angled Contour Zirconia Abutment | ZimVie US Corp LLC | NHA | Class II | |
| K083434 | Tt1 General Purpose Coil | Tursiop Technologies, LLC | MOS | Class II | |
| K083348 | Image-Arena Applications | TOMTEC Imaging Systems GmbH | LLZ | Class II | |
| K083344 | Heliodent Plus | Sirona Dental Systems GmbH | EHD | Class II | |
| K083249 | Quickie Rhythm | Sunrise Medical Hhg, Inc. | ITI | Class II | |
| K083049 | Tornado Rotatabel Snare and Polyp Catcher | Horizons Intl. Corp. | FDI | Class II | |
| K082909 | Rsvp Half Sphere Phantom, Model Ddp010 | Phantom Laboratory | IYE | Class II | |
| K082818 | Subcutaneous Needle Infusion Set | Marcal Medical, Inc. | FPA | Class II | |
| K082677 | Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite | American Medical Systems, Inc. | OTP | Class III | |
| K081971 | Bioclean Chemo Ultimate Powder Free Polychloroprene Examination Gloves | Nitritex (M) Sdn. Bhd. | LZC | Class I | |
| K081928 | D3 Duet Dfa Rsv/respiratory Virus Screening Kit | Ortho-Clinical Diagnostics, Inc. | LKT | Class I | |
| K081768 | Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles | Cook Incorporated | NAJ | Class II | |
| K081746 | D3 Duet Dfa Influenza A/respiratory Virus Screening Kit | Ortho-Clinical Diagnostics, Inc. | GNW | Class I | |
| K081173 | Endoscopic CO2 Regulation Unit Ucr | Olympus Medical Systems Corp. | HET | Class II | |
| K080766 | Vidas Rub Igg | bioMerieux, Inc. | LFX | Class II | |
| K083549 | Abt Glucose Control Solution | American Biological Technologies, Inc. | JJX | Class I | |
| K083476 | Noveon Model Ls1100-03 | Nomir Medical Technologies, Inc. | GEX | Class II | |
| K083173 | Vitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System | Ortho-Clinical Diagnostics, Inc. | JLW | Class II | |
| K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and Ip32-01 | Biokit, S.A. | KXT | Class II | |
| K082938 | Ezlase | Biolase MG LLC | GEX | Class II | |
| K082926 | Zuma, Model 55-Xxxx/56-Xxxx | Seaspine, Inc. | OVD | Class II | |
| K082829 | Aircraft Medical Oxygen Generation System (Amogs) | Mission Systems Davenport Inc. | OLF | Class II | |
| K082801 | Phantom Plus Cage System | Us Spine | ODP | Class II | |
| K082651 | Endosseous Dental Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K082637 | Cranial Perforator | The Anspach Effort, Inc. | HBF | Class II | |
| K081148 | Siemens Acuson 2000 Ultrasound System with Abvs Transducer | Siemens Medical Solutions USA, Inc., Ultrasound di | IYO | Class II | |
| K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems | Lin-Zhi International Inc | DJG | Class II | |
| K083254 | Aloka Prousound 2 Diagnostic Ultrasound System | Aloka Co., Ltd. | IYN | Class II | |
| K083084 | CT Brain Perfusion for Ziostation | Ziosoft, Inc. | LLZ | Class II | |
| K082993 | Surgiseal Topical Skin Adhesive | Adhezion Biomedical, LLC | MPN | Class II | |
| K082911 | Smoothcool Hr System | Jeisys Medical Inc. | GEX | Class II | |
| K082898 | Amedica Drug Screen Test Cup | Amedica Biotech, Inc. | NGL | Class II | |
| K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed | Instrumentation Laboratory Co. | GGN | Class II | |
| K082813 | Stryker LED Lightsource | Stryker Corp. | FCW | Class II | |
| K082758 | Prismaflo II | Stihler Electronic GmbH | KOC | Class II | |
| K082729 | Rimclose Bone Anchor | Anulex Technologies, Inc. | MBI | Class II | |
| K082643 | 3.5 Mm Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 Mm Angled Side Effect Electrode with Integrate | DePuy Mitek, Inc. | GEI | Class II | |
| K082639 | Zimmer Dental Tapered Swissplus Implants | ZimVie US Corp LLC | DZE | Class II | |
| K082630 | Vitalcheck Blood Pressure Cuff, Model Zvc4000 Series | Zefon Intl. | DXQ | Class II | |
| K082503 | Dimension Vista Lg Light Chains, Type Kappa, Dimension Vista Lg Light Chains, Type Lambda, Dimension Vista Protein 1 Cal | Siemens Healthcare Diagnostics Inc. | DFH | Class II | |
| K082114 | Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 | Apollo Endosurgery, Inc. | KNS | Class II |