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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | JAF | Class II | |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | MUJ | Class II | |
| K241998 | Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | GXY | Class II | |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals ApS | CHL | Class II | |
| K240924 | Anterion | Heidelberg Engineering GmbH | OBO | Class II | |
| K240779 | Vivo 3 | Breas Medical AB | MNT | Class II | |
| K240778 | Vivo 1, Vivo 2 | Breas Medical AB | MNS | Class II | |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | CBK | Class II | |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. ve Tic. A.S. | ETN | Class II | |
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam | MWJ | Class II | |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K243495 | Natus Ultrapro S100 (982A0594) | Medtronic, Inc. | GWF | Class II | |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | KIF | Class II | |
| K242832 | NExT Station; NExT Station Advanced | EB Neuro S.p.A. | GWL | Class II | |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | Terragene LLC | FRC | Class II | |
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | OPT | Class II | |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | KNS | Class II | |
| K241253 | Medicon Epiplating System | CMF Medicon Surgical Inc | FZE | Class II | |
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | EBD | Class II | |
| K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | NXC | Class II | |
| K243548 | BriefCase-Triage | Aidoc Medical Ltd. | QFM | Class II | |
| K243498 | Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation | JXM | Class II | |
| K243491 | SternalPlate Expansion | Stryker Leibinger GmbH & Co. KG | HRS | Class II | |
| K243369 | Cervical Plating System | Life Spine | KWQ | Class II | |
| K242747 | Faq™ (302) | Foreo Inc | OAP | Class II | |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | HRX | Class II | |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems, Inc. | MUJ | Class II | |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ | Class II | |
| K242033 | Access25™ Delivery Microcatheter | Penumbra Inc. | QJP | Class II | |
| K241873 | OsseoFit Stemless Shoulder System | Zimmer GmbH | PKC | Class II | |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | Zurimed Technologies AG | OWX | Class II | |
| K241088 | EndoTool IV (3.1) | Monarch Medical Technologies | NDC | Class II | |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | GXZ | Class II | |
| K240758 | Radiofrequency Generator System, Cura RF Electrode | Zhejiang Curaway Medical Technology Co., Ltd | GEI | Class II | |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | MWI | Class II | |
| K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | IYN | Class II | |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | |
| K242630 | Aerin Console | Aerin Medical, Inc. | GEI | Class II | |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K242461 | IRISeg | Intuitive Surgical, Inc. | QIH | Class II | |
| K242327 | Empulse M90 | Concourse Assistive Technology Pty Ltd | ITI | Class II | |
| K242025 | Elos Accurate® Hybrid Base™ | Elos MedTech Pinol a/S | NHA | Class II | |
| K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | |
| K241505 | DRX-Revolution Mobile X-ray System | Eastman Kodak Company | IZL | Class II | |
| K241391 | Straumann® PURE Ceramic Implants | Straumann USA, LLC | DZE | Class II | |
| K231216 | Potenza | Jeisys Medical Inc. | GEI | Class II | |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Smith & Nephew, Inc. | HSB | Class II |