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 |
|---|---|---|---|---|---|
| K212583 | AlignRT Plus | Vision Rt Inc | IYE | Class II | |
| K212284 | Disposable Automatic Core Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | KNW | Class II | |
| K212107 | Reverso | Intelis Instruments, Ltd. | GEI | Class II | |
| K212013 | eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. | DQD | Class II | |
| K212003 | ESSENZ Patient Monitor | LivaNova Deutschland GmbH | DXJ | Class II | |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | Caldera Medical, Inc. | OTN | Class II | |
| K211733 | Lunit INSIGHT CXR Triage | Lunit Inc. | QFM | Class II | |
| K211244 | VSP® Orthopedics System | 3D Systems, Inc. | PBF | Class II | |
| K210779 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Shandong Shangwei Medical Products Co.,Ltd | LZA | Class I | |
| K210344 | inVisionOS | Precisionos Technology, Inc. | LLZ | Class II | |
| K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | JOW | Class II | |
| K201082 | LTV2 Series Ventilators | Jaeger Medical GmbH | CBK | Class II | |
| K213383 | WHILL Model C2 | Whill, Inc. | ITI | Class II | |
| K212526 | Surgical Face Mask | Suzhou Janee Medical Technology Co., Ltd. | FXX | Class II | |
| K212331 | BodySculp | Rohrer Aesthetics, Inc. | PKT | Class II | |
| K211967 | Sensual Massage, Ultra Pure | Dreambrands, Inc. | NUC | Class II | |
| K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | DQK | Class II | |
| K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | Convergent Laser Technologies | GEX | Class II | |
| K211315 | Comby EEG Caps | Pamel d.o.o. | GXY | Class II | |
| K211289 | RMU-2000 Automated Chest Compression System | Defibtech LLC | DRM | Class II | |
| K211206 | FreedomEdge(R) Syringe Infusion System | Repro-Medical System, Inc., dba Koru Medical Systems | FRN | Class II | |
| K211165 | Medical Face Masks, Model Name:MY020003 | Huizhou Jie Bai Purification Co., Ltd. | FXX | Class II | |
| K202326 | BESPA Charcot System | Bespa Global, LLC | HWC | Class II | |
| K212956 | FDR Cross (DR-XD 3000) | FUJIFILM Corporation | OWB | Class II | |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28 | KTT | Class II | |
| K212787 | GT5 conductive & abrasive gel | Wuhan Greentek Pty Ltd. | GYB | Class II | |
| K212550 | Hura CTP v1.0 | Hura Imaging, Inc. | LLZ | Class II | |
| K212068 | Biotech Dental Kits | Biotech Dental SAS | KCT | Class II | |
| K211356 | GIQuant | Motilent Ltd | LLZ | Class II | |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience Inc | NBC | Class II | |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | Spectrum Medical Inc | DWF | Class II | |
| K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | EFB | Class I | |
| K212506 | Medical Examination Gloves (Tested for Use with Chemotherapy) | Guangdong Gymda Medical Technology Co.,Ltd | LZA | Class I | |
| K212504 | Isolation Gown AAMI Level 3 | Kenpax International Limited | FYC | Class II | |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K212896 | Visible Patient Suite | Visible Patient, SAS | LLZ | Class II | |
| K212853 | Cervical Stand-Alone System | Eminent Spine | OVE | Class II | |
| K212707 | CoolSculpting Elite System | Zeltiq Aesthetics Inc | OOK | Class II | |
| K212551 | Nitrile Examination Gloves | Anhui Fine Glove Medical Technology Co., Ltd. | LZA | Class I | |
| K212523 | VFSS Pro Mobile Digital Imaging System | Imagexray, LLC | OWB | Class II | |
| K212502 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | |
| K212485 | Disposable Nitrile Examination gloves | Fujian Yuanxin Safety Protection Technology Co., Ltd. | LZA | Class I | |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | Guangzhou Zhengkang Medical Equipment Co.,Ltd | FXX | Class II | |
| K212044 | TrueLok Evo | Orthofix SRL | KTT | Class II | |
| K211971 | Drug Relief v1 | Dyansys, Inc. | PZR | Class II | |
| K211817 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | |
| K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K211577 | SoftFix Balloon Trocar | Unimax Medical Systems Inc. | GCJ | Class II | |
| K211055 | Microcurrent device (Model: HBR2-1) | Shenzhen DJ Medical Equipment Co., Ltd. | NFO | Class II | |
| K210859 | NextAR™ Spine Platform | Medacta International SA | SBF | Class II |