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 |
|---|---|---|---|---|---|
| K200466 | Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | IOR | Class I | |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Ansell Healthcare Products LLC | LZA | Class I | |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | Shenzhen Osto Technology Company Limited | NUH | Class II | |
| K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | EMA | Class II | |
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited | IYE | Class II | |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | MXD | Class II | |
| K210021 | Axon Therapy | Neuralace Medical | QPL | Class II | |
| K203818 | Replens Long-Lasting Vaginal Moisturizer | Church & Dwight Co., Inc. | NUC | Class II | |
| K203732 | Surgical Face Mask | Zhuhai Gaoge Medical Technology Co., Ltd. | FXX | Class II | |
| K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | Fci (France Chirurgie Instrumentation) SAS | NCB | Class II | |
| K203215 | Radius T wearable thermometer | Masimo Corporation | FLL | Class II | |
| K203030 | Powder Free Nitrile Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co Ltd | FRA | Class II | |
| K202714 | Medical Face Mask | Chongqing Chaoke Industry Development Co., Ltd. | FXX | Class II | |
| K211590 | Fiducial Marker | Carbon Medical Technologies, Inc. | IYE | Class II | |
| K211469 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | HEB | Class II | |
| K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) | Thrombolex, Inc. | QEY | Class II | |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit | CC Wellness LLC | NUC | Class II | |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two | CC Wellness LLC | NUC | Class II | |
| K210767 | Surgical Masks, Model:FE-1 | Hunan Triplex Precision Medical Devices Co., Ltd. | FXX | Class II | |
| K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K210522 | Disposable Vinyl Examination Gloves | Shandong Shengshixincheng Medical Science & Technology Co. | LYZ | Class I | |
| K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | BRZ | Class II | |
| K210015 | Surgical Face Mask | Sample King Manufacturing, Ltd. | FXX | Class II | |
| K203779 | Symmetric Total Knee System | Whiteside Biomechanics, Inc. | MBH | Class II | |
| K203756 | Disposable Surgical Mask | Lucky Textile Industrial(Wuxi) Co., Ltd. | FXX | Class II | |
| K203629 | IDx-DR | Digital Diagnostics Inc. | PIB | Class II | |
| K201493 | Spirometer | Mehow Innovative Ltd | BZG | Class II | |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | Stryker Corp. | ERL | Class II | |
| K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K211216 | Vivid S60N / Vivid S70N | GE Healthcare | IYN | Class II | |
| K210591 | Palm Bladder Scanner - PBSV7.1 | Mianyang Meike Electronic Equipment Co.,Ltd. | IYO | Class II | |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical, Inc. | JDI | Class II | |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care Inc. | NRY | Class II | |
| K211062 | Medical Face Mask | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | FXX | Class II | |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | Abbott Medical | NQQ | Class II | |
| K202126 | Disposable Surgical Mask | Shenzhen Peninsula Medical Co., Ltd. | FXX | Class II | |
| K210641 | Disposable Medical Mask | Tuosheng Protective Products (Ningbo) Co., Ltd. | FXX | Class II | |
| K210433 | Surgical Face Mask (Ear loops and Tie-on) | Wuhan Dymex Healthcare Co., Ltd. | FXX | Class II | |
| K210372 | Disposable Surgical Mask | Dongguan Shin YI Healthcare Products Factory | FXX | Class II | |
| K210050 | Augmented VaultLock Glenoid | Arthrex GmbH | KWS | Class II | |
| K203802 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | |
| K202663 | Suture Wing | Osteonic Co., Ltd. | MBI | Class II | |
| K202580 | Disposable Surgical Mask | Qingdao Likangyuan Medical Device Co.,Ltd. | FXX | Class II | |
| K201914 | HRVWatch-Mini Wrist Monitor | Taiwan Scientific Corporation | DXN | Class II | |
| K193383 | SnugKap | Headstart, Ltd. | MVA | Class II | |
| K211473 | Micro C Medical Imaging System, M01 | Oxos Medical Inc | IZL | Class II | |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | Bard Peripheral Vascular Inc | MSD | Class II |