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 |
|---|---|---|---|---|---|
| K230037 | Back 3 | Swims America Corp | PBX | Class II | |
| K223151 | Nu-beca Transcutaneous Electrical Nerve Stimulation | Nu-Beca & Maxcellent Co. | NUH | Class II | |
| K210801 | AXINON® LDL-p Test System | Numares AG | MRR | Class I | |
| DEN220047 | Galen ES Cooperative Surgical Assistant Platform, Galen ES | Galen Robotics | QXG | Class II | |
| K230945 | Forma Medical Headless Compression Screw | Forma Medical, Inc. | HWC | Class II | |
| K230716 | Robotic Graft Delivery Instruments | Medtronic Sofamor Danek | OLO | Class II | |
| K223339 | Bone Chamber Implant | Megagen Implant Co., Ltd. | DZE | Class II | |
| K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | FMF | Class II | |
| K221107 | Trust | Rgorithm Korea | PNP | Class II | |
| K213100 | FMT Reusable Temperature Probes | Metko Medikal ve Ttbbi Cihazlar D1s Ticaret Ltd. Sti | FLL | Class II | |
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | Avitus Orthopaedics, Inc | FMF | Class II | |
| K231441 | ARIX Ankle System | Jeil Medical Corporation | HRS | Class II | |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation | JOJ | Class II | |
| K230462 | OPTIX H2 Patient Specific Instrument System | Vilex LLC | HSN | Class II | |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | OWN | Class II | |
| K230395 | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) | Durio Ppe Sdn. Bhd. | FXX | Class II | |
| K230257 | Arthrex Intramedullary Nails | Arthrex GmbH | HSB | Class II | |
| K230087 | “POINT” Kinguide Agile Hybrid Navigation System | Point Robotics MedTech Inc. | OLO | Class II | |
| K230077 | LaserME | Neauvia North America, Inc | GEX | Class II | |
| K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | Exactech, Inc. | JWH | Class II | |
| K222683 | Fibroid Mapping Reviewer Application (FMRA) | Nesa Medtech Private Limited | LLZ | Class II | |
| K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | Becton Dickinson & Co | JKA | Class II | |
| K211143 | Pulse Oximeter | Shenzhen Brav Electronic Technologies Co., Ltd | DQA | Class II | |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System | K&J Consulting Corp. | KWQ | Class II | |
| K231841 | PathLoc SI Joint Fusion System | L&K Biomed Co.,Ltd. | OUR | Class II | |
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | CAC | Class II | |
| K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd | QIH | Class II | |
| K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) | Navinetics Inc | HAW | Class II | |
| K231041 | JiveX (Model Number / Release: 5.4) | Visus Health IT GmbH | LLZ | Class II | |
| K230445 | OnX Tough | Sprintray Inc. | EBI | Class II | |
| K230269 | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | JCT | Class II | |
| K230016 | Cercare Medical Neurosuite | Cercare Medical a/S | LLZ | Class II | |
| K223886 | Wearable Breast Pump (Model S18) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K223791 | TalWire | Embrace Medical Ltd. | DQX | Class II | |
| K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | Sentiar, Inc. | LLZ | Class II | |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | ELC | Class II | |
| K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Brainlab, Inc. | QIH | Class II | |
| K222026 | Neodent Implant System - Zirconia Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K221673 | Bonafix TiBase | Zentek Medical LLC | NHA | Class II | |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Medical | GJS | Class II | |
| DEN230012 | Ruthless Spine RJB | Ruthless LLC dba Ruthless Spine | QWL | Class II | |
| K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K231769 | activL® Next Generation Instrumentation | Aesculap Implants Systems, LLC | QLQ | Class II | |
| K231754 | Praxiject™ 0.9% NaCl | Medxl, Inc. | NGT | Class II | |
| K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | EHD | Class II | |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K231351 | Chondral Quant | Siemens Medical Soultions USA, Inc. | LLZ | Class II | |
| K231064 | ReddyPort Elbow | SMD Manufacturing LLC | MNS | Class II |