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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K180581 | UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH | LEJ | Class II | |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories Inc. | MRG | Class II | |
| K180493 | A3 Total Knee System | Beijing AK Medical Co, Ltd | JWH | Class II | |
| K180331 | Wireless Pain Relieve Device | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | |
| K180282 | MIS Internal Hex Dental Implant System | MIS Implants Technologies Ltd. | DZE | Class II | |
| K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine | KWQ | Class II | |
| K180152 | gel-e Flex | Gel-E, Inc. | QSY | Unclassified | |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | IYO | Class II | |
| K173414 | Advance Biliary Balloon Catheter | Cook Incorporated | GCA | Class II | |
| K173066 | OSSEODUO Shaver and Drill System | Bien-Air Surgery SA | HBC | Class II | |
| K172779 | AIROS 8 Sequential Compression Device | Airos Medical Inc | JOW | Class II | |
| K172770 | AIROS 6 Sequential Compression Device | Airos Medical Inc | JOW | Class II | |
| K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | DRT | Class II | |
| K170826 | Perfadex Plus | Xvivo Perfusion, Inc. | KDN | Class II | |
| K151721 | Fiji Sun Fluorescent Tanning Unit | Kdb Inc. (dba) Sperti Sunlamp | LEJ | Class II | |
| DEN170004 | Ellipsys Vascular Access System | Avenu Medical, Inc. | PQK | Class II | |
| DEN160006 | everlinQ endoAVF System | Tva Medical, Inc. | PQK | Class II | |
| K181437 | Pure Vu System | MOTUS GI Medical Technologies Ltd. | FDF | Class II | |
| K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated | Medtronic, Inc. | GEI | Class II | |
| K180809 | Eclipse II | Eastman Kodak Company | MQB | Class II | |
| K180791 | Straumann BLX Surgical Cassette | Straumann USA, LLC | KCT | Class II | |
| K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | PHX | Class II | |
| K173348 | 0.9% Sodium Chloride Injection, USP | MEDLINE INDUSTRIES, LP - Northfield | NGT | Class II | |
| K173028 | BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software | Healthstats International Pte., Ltd. | DXN | Class II | |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional | Synthes (USA) Products, LLC / Depuy Orthopaedics, Inc. | JDQ | Class II | |
| K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | FMI | Class II | |
| K170886 | HOMED Mesh Nebulizer | Shenzhen Homed Medical Device Co Ltd | CAF | Class II | |
| K181368 | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) | bioMerieux, Inc. | NGZ | Class II | |
| K181364 | Swiss LithoClast Trilogy | E.M.S. - Electro Medical Systems SA | FEO | Class II | |
| K181358 | Televere Digital Dental Imaging System | Televere Systems | MUH | Class II | |
| K181348 | Cartiva SCI Disposable Instrumentation Set | Cartiva, Inc. | QBO | Class II | |
| K180911 | Visura Technologies TEECAD System | Visura Technologies, Inc. | FDS | Class II | |
| K180885 | HairMax Laser | Lexington International, LLC | OAP | Class II | |
| K180743 | Balanced Knee Revision System - Offset Junction Box | Ortho Development Corp. | JWH | Class II | |
| K180377 | Fracture and Correction System | In2bones USA, LLC | HWC | Class II | |
| K180008 | Penumbra System | Penumbra Inc. | NRY | Class II | |
| K173147 | SuperNO2VA Et Device | Revolutionary Medical Devices, Inc. | CCK | Class II | |
| K172536 | Atlas Percussion Adjusting Instrument | Spinalight Inc | LXM | Unclassified | |
| K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform | Medtronic, Inc. | GEI | Class II | |
| K180856 | Neutrogena Light Therapy Aging Mask+ | Kenvue Brands LLC | OHS | Class II | |
| K180847 | Neutrogena Light Therapy Acne Mask+ | Kenvue Brands LLC | OLP | Class II | |
| K180710 | Reprocessed DecaNav Diagnostic Electrophysiology Catheter | Innovative Health, LLC. | NLH | Class II | |
| K180472 | ViSi Mobile Monitoring System | Sotera Wireless | MHX | Class II | |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi Inc. | EBW | Class I | |
| K173700 | PICOPLUS Laser System | Lutronic Corporation | GEX | Class II | |
| K173316 | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device | Transmed7, LLC | KNW | Class II | |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | Bionime Corporation | NBW | Class II | |
| K172346 | sterEOS Workstation | EOS imaging | LLZ | Class II | |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | Zirkonzahn SRL | EBF | Class II | |
| K180761 | SD LTM STIM Cortical Stimulator | MicroMed, LLC | GYC | Class II |