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 |
|---|---|---|---|---|---|
| K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | Abbott Medical | DQK | Class II | |
| K201146 | Ion Endoluminal System | Intuitive Surgical, Inc. | EOQ | Class II | |
| K201119 | ChartCheck | Radformation, Inc. | IYE | Class II | |
| K200840 | DuoHex CH Cannulated Hammertoe System | Medartis AG | HWC | Class II | |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense | Hycor Biomedical | DHB | Class II | |
| K200760 | Rapid ASPECTS | Ischemaview, Inc. | POK | Class II | |
| K200736 | Stardust Med | I.T.S. Group S.r.l. | GEX | Class II | |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc | PGW | Class II | |
| K200720 | D-Stat Radial Topical Hemostat | Vascular Solutions LLC | QSX | Unclassified | |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | Megadyne Medical Products, Inc | FYD | Class II | |
| K200226 | RetroFix | Retrofix Screws, LLC | HWC | Class II | |
| K200095 | Streamline Navigated Instruments | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | OLO | Class II | |
| K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | FGE | Class II | |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | Horiba Abx SAS | CZP | Class II | |
| K193473 | LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US | Boston Scientific Corporation | MXD | Class II | |
| K193042 | Optimized Positioning System (OPS) ReView | Corin USA | LLZ | Class II | |
| K191443 | MSDI Dental Implants System | Medical Systems and Devices International Ltd. | DZE | Class II | |
| K182081 | JDentalCare Implant System JDIcon | Jdentalcare SRL | DZE | Class II | |
| K201414 | Rotium Bioresorbable Wick | Nanofiber Solutions LLC | MAI | Class II | |
| K200834 | Lever Action Plate System | Mcginley Orthpaedic Innovations, LLC | HRS | Class II | |
| K200815 | VitriGuard | CooperSurgical, Inc. | MQK | Class II | |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | LBH | Class II | |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies Ltd. | KRA | Class II | |
| K200437 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd | DXN | Class II | |
| K200295 | IlluminOss Bone Stabilization System | Illuminoss Medical Inc. | QAD | Class II | |
| K200175 | DIA-ROOT BIO Sealer | Diadent Group International | KIF | Class II | |
| K193348 | Blood Pressure Monitor | Shenzhen Viatom Technology Co., Ltd. | DXN | Class II | |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | Implant Direct Sybron Manufacturing LLC | DZE | Class II | |
| K192028 | Yumizen C1200 CRP | Horiba Abx SAS | DCK | Class II | |
| K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K200855 | Cina | Avicenna.ai | QAS | Class II | |
| K200663 | ControlRad Trace Model 9 | Controlrad, Inc. | OWB | Class II | |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | GA Health Company Limited | ODC | Class II | |
| K200445 | The C100 Contactless Breathing Monitor | Circadia Technologies, Ltd. | BZQ | Class II | |
| K193477 | Nd: YAG Laser Therapy Systems | Beijing Kes Biology Technology Co., Ltd. | GEX | Class II | |
| K192710 | The Simple Locking Intramedullary (Slim) System | Orthopediatrics Canada ULC | HSB | Class II | |
| K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBF | Class II | |
| K201096 | CO2mbiLED | Karl Storz Endoscopy-America, Inc. | FCX | Class II | |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K200772 | ULab Systems uDesign Software | uLab Systems, Inc | PNN | Class II | |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | Richard Wolf Medical Instruments Corp. | FET | Class II | |
| K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | |
| K201151 | O-Mec 690 Series Laparoscopes | Omec Medical NV Inc | GCJ | Class II | |
| K201140 | Axeos | Dentsply Sirona Inc | OAS | Class II | |
| K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro) | Gtg Wellness Co., Ltd. | OHS | Class II | |
| K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard Inc | MSD | Class II | |
| K200195 | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter | Northeast Scientific Inc. | OBJ | Class II | |
| K192549 | Byteflies Kit | Byteflies NV | OMC | Class II | |
| K192466 | Air Compression Therapy System | Shenzhen Lifotronic Technology Co.,Ltd. | IRP | Class II |