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 |
|---|---|---|---|---|---|
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | JEY | Class II | |
| K220230 | AMSure Enteral Feeding Pump | Amsino International, Inc. | LZH | Class II | |
| K213294 | Dermal Cooling System | R2 Technologies, Inc. | QPZ | Class II | |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica S.P.A | GYC | Class II | |
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg | Boston Scientific Corporation | FAD | Class II | |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | HQF | Class II | |
| K222754 | ViewMate Multi Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | IYN | Class II | |
| K222497 | Zaga Zygomatic System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K222198 | Exo Iris (El2001) | Exo Imaging, Inc. | IYN | Class II | |
| K222166 | Solix | Optovue Inc. | OBO | Class II | |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd | FAJ | Class II | |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co. KG | JEY | Class II | |
| K221539 | GammaTile | GT Medical Technologies | KXK | Class II | |
| K220334 | MONET Anterior Cervical Plate System | CTL Medical Corporation | KWQ | Class II | |
| K203035 | Eonis SCID-SMA kit | Revvity Health Sciences, Inc. | PJI | Class II | |
| DEN200044 | Eonis SCID-SMA Kit | Revvity Health Sciences, Inc. | QUE | Class II | |
| K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System | Medtronic, Inc. | DQY | Class II | |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | Diversatek Healthcare Inc | OCX | Class II | |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | |
| K222132 | Hisense LCD monitor HMD2G21S, HMD3G21S | Qingdao Hisense Medical Equipment Co.,Ltd. | PGY | Class II | |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | QFM | Class II | |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | |
| K203812 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | DQA | Class II | |
| K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | DQK | Class II | |
| K222936 | Humeris® 135 Shoulder System | Fx Shoulder USA, Inc. | PHX | Class II | |
| K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | Safesource Direct | LZA | Class I | |
| K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | Medtronic, Inc. | DQY | Class II | |
| K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) | Sanhe Laserconn Tech Co., Ltd. | GEX | Class II | |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. | ELW | Class II | |
| K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd | KRA | Class II | |
| K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences LLC | DXN | Class II | |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | EGS | Class I | |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | HIS | Class II | |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | EGS | Class I | |
| K212317 | Eclipse MINI Model 98900 | GE Healthcare | MWJ | Class II | |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | DiaSorin Molecular LLC | QDZ | Class II | |
| K223164 | Aquilo Sports CCT1500 System | Aquilo Sports L.L.C. | IRP | Class II | |
| K223062 | World Total Knee System | Signature Orthopaedics Pty Limited | JWH | Class II | |
| K222697 | Disposable Medical Face Mask (DF3-001) | Wellmed Dental Medical Supply Co., Ltd | FXX | Class II | |
| K222639 | VHA Radiotherapy Bolus | Vha Dean | IXI | Class II | |
| K222453 | Self-adhesive Electrode | Guangdong Comytens Medical Technology Co., Ltd. | GXY | Class II | |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMI | Class II | |
| K222049 | Yomi Robotic System | Neocis Inc. | QRY | Class II | |
| K221822 | BENCHMARK BMX81 Access System | Penumbra Inc. | QJP | Class II | |
| K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corp. | LPH | Class II | |
| K221659 | Luminopia One | Luminopia Inc | QQU | Class II | |
| K221610 | Nextra CH Cannulated Hammertoe System | Medartis AG | HWC | Class II | |
| K221162 | UniVy OsteoVy Cervical IBF System | VY Spine, LLC | ODP | Class II | |
| K221086 | CryoRobot Select System | TMRW LIFE SCIENCES, Inc. | QUJ | Class II |