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 |
|---|---|---|---|---|---|
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | Assure Tech. (Hangzhou) Co., Ltd. | DJG | Class II | |
| K212204 | Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | CD Diagnostics, Inc | QGN | Class II | |
| K211993 | Z-LINKPC System | Zavation Medical Products, LLC | NKG | Class II | |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2Bones SAS | HSN | Class II | |
| K211552 | Surgical mask | Shandong Shengquan New Materials Co., Ltd. | FXX | Class II | |
| K211353 | Medical Face Mask | Shenzhen Lyttop Healthcare Limited | FXX | Class II | |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Medical | QLG | Class II | |
| K210759 | Solo, Swing Maxi | Medela AG | HGX | Class II | |
| K210687 | CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | |
| K203643 | Sensatronic Reusable Temperature Probes | Sensatronic GmbH | FLL | Class II | |
| K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K203152 | Disposable Face Mask | Chaozhou Cecilia Technology Co., Ltd. | FXX | Class II | |
| K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K211873 | PSX Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont | KIF | Class II | |
| K211640 | Ponto 5 Mini | Oticon Medical AB | LXB | Class II | |
| K211414 | KHEIRON Spinal Fixation System | S.M.A.I.O | NKB | Class II | |
| K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontologica | OAS | Class II | |
| K210730 | Nitrile Patient Examination Glove | American Performance Polymers, LLC | LZA | Class I | |
| K201026 | sOLVe Tube | Hytek Medical, Inc. | CBI | Class II | |
| K211540 | Edma Synthetic Nitrile Examination Gloves | Edma Group, LLC | LZA | Class I | |
| K211300 | X-Cube 90 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K211299 | X-Cube 70 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | Boston Scientific Corporation | EOQ | Class II | |
| K211354 | Disposable Synthetic Vinyl Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | |
| K212100 | Kosmos | Echonous Inc | IYN | Class II | |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | |
| K211783 | TriMed Threaded Intramedullary Nail System | Trimed Inc | HWC | Class II | |
| K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | KPS | Class II | |
| K211725 | Senographe Pristina | GE Healthcare | MUE | Class II | |
| K211435 | PAO Cortical Screw | Medacta International SA | HWC | Class II | |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker Corp. | GWG | Class II | |
| K210725 | Nitrile Patient Examination Glove | Pingan Medical Products Co., Ltd. | LZA | Class I | |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | IZQ | Class II | |
| K210320 | ClearCorrect System | ClearCorrect, LLC | NXC | Class II | |
| K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | MMK | Class II | |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | NOE | Class II | |
| K200193 | Kisses Plus Implant System | Achimhai Medical Corporation | NHA | Class II | |
| K211893 | SelectFlex Neurovascular Access System Family | Q'apel Medical, Inc. | QJP | Class II | |
| K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | LZO | Class II | |
| K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | Jiangsu Cureguard Glove Co., Ltd. | LZA | Class I | |
| K211434 | Nitrile Patient Examination Gloves | Zhangjiagang Huayuan Protective Equipment Co., Ltd. | LZA | Class I | |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 4Web Medical, Inc. | MAX | Class II | |
| K211075 | Disposable Medical Nitrile Examination Gloves (Non-Sterile) | Jiangsu Cherish Medical Technology Co., Ltd. | LZA | Class I | |
| K210680 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | MSC | Class II | |
| K203362 | TRACOE vario | Tracoe Medical GmbH | JOH | Class II | |
| K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | QPZ | Class II | |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | JEY | Class II | |
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems Inc. | OLW | Class II |