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 |
|---|---|---|---|---|---|
| K201389 | Resoundant Acoustic Driver System | Resoundant, Inc. | LNH | Class II | |
| K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., dba Stryker Orthopaedics | JWH | Class II | |
| K201299 | HD Steth | Hd Medical, Inc. | DQD | Class II | |
| K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | JAQ | Class II | |
| K201243 | Disposable Specimen Retrieval Bag | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | GCJ | Class II | |
| K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie SAS | MWI | Class II | |
| K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | B&J Manufacturing, Ltd. | JOW | Class II | |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | BZD | Class II | |
| K200450 | X-Cube 70 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K200449 | X-Cube 90 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K200427 | Sonicision Cordless Ultrasonic Dissector | Medtronic, Inc. | LFL | Unclassified | |
| K200409 | Pelvital System | Pelvital USA, Inc. | HIR | Class II | |
| K200203 | Infrascanner | Infrascan, Inc. | OPT | Class II | |
| K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | OLO | Class II | |
| K193624 | Automatic Upper Arm Blood Pressure Monitor | Dongguan e-Test Technology Co.,Ltd | DXN | Class II | |
| K193559 | NextAR TKA Platform | Medacta Inernational SA | SBF | Class II | |
| K193294 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28 | HSN | Class II | |
| K192969 | Ezra Plexo Software | Ezra AI, Inc. | QIH | Class II | |
| K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | KPR | Class II | |
| K201586 | XACT Robotic System | Xact Robotics, Ltd. | JAK | Class II | |
| K201296 | i-Rapha Solution | Irm, Inc. | LLZ | Class II | |
| K201035 | ETHICON Linx Esophagus Sizing Tool | Torax Medical, Inc. | QJN | Class II | |
| K200941 | Rapid LVO | Ischemaview, Inc. | QAS | Class II | |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer GmbH | JDI | Class II | |
| K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | IZL | Class II | |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) | Galil Medical Ltd. | NEY | Class II | |
| K193272 | GTK Trocars | Guangzhou T.K Medical Instrument Co., Ltd. | GCJ | Class II | |
| K193113 | GC Temp Print | GC America Inc. | EBG | Class II | |
| K192928 | Optiflux Enexa F500 Dialyzer | Fresenius Medical Care Reanal Therapies Group, LLC | KDI | Class II | |
| K201593 | Looking Glass 4K Integrated Visualization System | ConMed Corporation | GCJ | Class II | |
| K201575 | CMDR 2C (Multiple Models) | Minxray Inc | IZL | Class II | |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | KCI USA, Inc. | OMP | Class II | |
| K201556 | Intraosseous Fixation System | Extremity Medical, LLC | HWC | Class II | |
| K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex GmbH | PKC | Class II | |
| K201307 | VisCalor | Voco GmbH | EBF | Class II | |
| K201216 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | DXZ | Class II | |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn SRL | EBG | Class II | |
| K200656 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.p.A. | LPH | Class II | |
| K200599 | Digital Thermometer | Joytech Healthcare Co., Ltd. | FLL | Class II | |
| K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | B&J Manufacturing, Ltd. | JOW | Class II | |
| K193345 | Arthrex DynaNite Compression Plate | Arthrex GmbH | HRS | Class II | |
| K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd | EIH | Class II | |
| K200392 | Rexsin | Sm Eng Co., Ltd. | GAM | Class II | |
| K201540 | uMR570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K201235 | Arthrex MaxForce MTP Compression Plates and Screws | Arthrex GmbH | HRS | Class II | |
| K200850 | Fujifilm Ultrasonic Processor | FUJIFILM Corporation | FDS | Class II | |
| K200652 | Lollipop BiteBlock | Radtec Medical Devices, Inc. | IYE | Class II | |
| K200330 | RC-Prime Root Canal Preparation Cream | Pac-Dent Inc. | KJJ | Unclassified |