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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | LYY | Class I | |
| K202676 | Disposable Medical Face Mask | Zhejiang Senhong Medical&Instrument Co., Ltd. | FXX | Class II | |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | GZI | Class II | |
| K212937 | Dakota ALIF Plate System | Precision Spine, Inc. | KWQ | Class II | |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | b-ONE Ortho Corp. | MAI | Class II | |
| K212897 | IPL Hair Removal Device, model: AI01 | Shenzhen Century Dongyuan Technology Co. Ltd | OHT | Class II | |
| K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) | Stryker Corp. | GCJ | Class II | |
| K212510 | 7 Series Phototherapy Device | The Daavlin Distributing Co. | FTC | Class II | |
| K212496 | Ortho Aligner System | Ortho Lab Services, LLC | NXC | Class II | |
| K212471 | Medical Face Mask | Haian Medigauze Co., Ltd. | FXX | Class II | |
| K212467 | Disposable Nitrile Examination Glove | Inner Mongolia Boming Medical Supplies Co., Ltd. | LZA | Class I | |
| K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | Jiangsu Micsafe Medical Technology Co., Ltd | JKA | Class II | |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp | PHX | Class II | |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH | DXN | Class II | |
| K211103 | Powder Free Vinyl Examination Gloves | Shanghai Shengda Medical Applications Co., Ltd. | LYZ | Class I | |
| K210628 | X-FLO Fluid Management System | Thermedx LLC | HIG | Class II | |
| K210384 | Carescape R860 | GE Healthcare | CBK | Class II | |
| K212537 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | OLO | Class II | |
| K212515 | MOVIX DReamy | Stephanix | IZL | Class II | |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | KWQ | Class II | |
| K212404 | S.I.N. Instrument Kits | S.I.N. Implant System Ltda | KCT | Class II | |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | Merit Medical Systems, Inc. | QEZ | Class II | |
| K212151 | FLUME catheter | The Flume Catheter Company Ltd | EZL | Class II | |
| K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | KNG | Class II | |
| K211947 | GlideScope BFlex 2.8 Single-Use Bronchoscope | Verathon Medical (Canada) ULC | EOQ | Class II | |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | Brainlab, Inc. | HAW | Class II | |
| K210969 | Nulife | Mrk Healthcare Pvt, Ltd. | KGO | Class I | |
| K210543 | Im007 | Implicity | DQK | Class II | |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek Inc. | IYN | Class II | |
| K203372 | SyMRI | Syntheticmr AB | LNH | Class II | |
| K202732 | SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group | LHI | Class II | |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Spectrum Medical Inc | KFM | Class II | |
| K191964 | BD Kiestra IdentifA | Becton Dickinson & Co | QQV | Class II | |
| DEN200040 | OMNIgene GUT Dx | DNA Genotek Inc. | QPO | Class II | |
| K213326 | VisionX 3.0 | Durr Dental SE | LLZ | Class II | |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | OWY | Class II | |
| K210921 | TaiChiB | Our United Corporation | IYE | Class II | |
| K210777 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Shandong Jieshi Medical Products Co.,Ltd | LZA | Class I | |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair LGL | PIF | Class II | |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S. | EMA | Class II | |
| K210222 | Disposable Medical Mask | Guangdong Lide Medical Technology Co., Ltd. | FXX | Class II | |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) | Guangzhou Xinbo Electronic Co., Ltd | NGX | Class II | |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | Enztec Limited | MAX | Class II | |
| K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg Inc. | FRG | Class II | |
| K212171 | Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd | DXN | Class II | |
| K211586 | Nitrile Examination Gloves (Blue, Violet) | Lyncmed Medical Technology (Beijing) Co., Ltd. | LZA | Class I | |
| K211079 | BioFire COVID-19 Test 2 | BioFire Defense, LLC | QQX | Class II | |
| K210499 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | DZE | Class II | |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | LZA | Class I | |
| K212403 | Tracheal Stent System (Y-Shaped) | Micro-Tech (Nanjing) Co., Ltd. | JCT | Class II |