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 |
|---|---|---|---|---|---|
| K203146 | Akesis Galaxy RTi | Akesis Inc. | IWB | Class II | |
| K203054 | FlexSys | Gme German Medical Engineering GmbH | GEX | Class II | |
| K202913 | NeuroCap (Model DEC22) | Memory MD, Inc. | GXY | Class II | |
| K202838 | Andorate Universal Endoscope Tip Guard | GA Health Company Limited | OCU | Class II | |
| K202693 | NeoWave Pain Relief and Recovery System, Model# T16-2020 | Eva Medtec, Inc | IRP | Class II | |
| K202658 | Vivid E80/ Vivid E90/ Vivid E95 | GE Healthcare | IYN | Class II | |
| K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum Ltd | POK | Class II | |
| K202078 | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove | Shen Wei (USA), Inc. | LZA | Class I | |
| K202076 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors | Shen Wei (USA), Inc. | LZA | Class I | |
| K201775 | NuVision ICE Catheter | Nuvera Medical, Inc. | OBJ | Class II | |
| K201420 | Republic Spine Dark Star Spinal System | Republic Spine | NKB | Class II | |
| K201285 | InMode Evolve System with the Tone Applicator | Inmode Ltd. | IPF | Class II | |
| K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) | Maxstar Industrial Co Ltd | IRP | Class II | |
| DEN200006 | ClearUP Sinus Relief | Tivic Health Systems, Inc. | QNU | Class II | |
| K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 | Medtronic, Inc. | DXC | Class II | |
| K210307 | Cios Select (VA21) Image Intensifier | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K210225 | Surgical Face Mask | Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. | FXX | Class II | |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ | Unimed Medical Supplies Inc | CCK | Class II | |
| K210006 | MI DeTACH | Biorep Technologies, Inc. | DXC | Class II | |
| K203387 | AlignRT Plus | Vision Rt Inc | IYE | Class II | |
| K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of BD] | MHC | Class II | |
| K202137 | Disposable medical mask | U-Play Products Corporation | FXX | Class II | |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | Hill-Rom Inc. | BZQ | Class II | |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | PZX | Class II | |
| K210282 | WIRION Embolic Protection System | Cardiovascular Systems Incorporated | NTE | Class II | |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | NPL | Class II | |
| K210277 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | FRC | Class II | |
| K210262 | Biograph Vision Quadra PET/CT System | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | AAP Implantate AG | HRS | Class II | |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | MAH | Class II | |
| K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform | Imperative Care Inc. | QJP | Class II | |
| K203576 | FORZA Ti Spacer System | Orthofix SRL | MAX | Class II | |
| K203521 | FineCross M3 | Ashitaka Factory of Terumo Corp. | DQY | Class II | |
| K202879 | EOGas 4 Endo-SteriTest RRBI | Andersen Sterilizers, Inc. | FRC | Class II | |
| K202518 | Promaxo MRI System | Promaxo, LLC | LNH | Class II | |
| K202316 | Medical mask (Model: KKF-1A) | Han Zhaoqing Sporting Goods Company Limited | FXX | Class II | |
| K201674 | Cultura Collection and Transport System | Merit Medical Systems, Inc. | JSM | Class I | |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | MQB | Class II | |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | OCW | Class II | |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International SA | KRO | Class II | |
| K203755 | Shoulder System - TiNbN Coating | Medacta International SA | PHX | Class II | |
| K203653 | MRI PPG Patient Cable | Ivy Biomedical Systems, Inc. | LNH | Class II | |
| K203617 | MaxFOV 2 | GE Healthcare | JAK | Class II | |
| K203394 | PleuraFlow System with FlowGlide | Clearflow, Inc | OTK | Class II | |
| K203086 | X-Plo2r | Belluscura, LLC | CAW | Class II | |
| K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | HRS | Class II | |
| K202356 | Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | |
| K202214 | IFM Surgical Mask Model SM3 | Fssc, LLC | FXX | Class II |