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 |
|---|---|---|---|---|---|
| K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | PGY | Class II | |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | KWQ | Class II | |
| K251594 | truFlex | Syrma Johari MedTech Limited | NGX | Class II | |
| K251484 | Ct:vq | 4DMEDICAL Limited | JAK | Class II | |
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd | NUH | Class II | |
| K250788 | Definium Tempo Select | GE Hualun Medical Systems Co., Ltd. | KPR | Class II | |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | CCK | Class II | |
| K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | QOG | Class II | |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | CBK | Class II | |
| K252419 | Hotwire RF Guidewire (901Xxx); Hotwire RF Guidewire (902Xxx) | Atraverse Medical | DXF | Class II | |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | NFT | Class II | |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd | EOQ | Class II | |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology Inc. | LZA | Class I | |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co., Ltd. | MQL | Class II | |
| K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd | NXC | Class II | |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | HWC | Class II | |
| K251068 | KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. | OCT | Class II | |
| K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | QIH | Class II | |
| K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | Nanjing Yinuoji Medical Technology Co., Ltd. | CAW | Class II | |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | Qiagen | QOF | Class II | |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | HRX | Class II | |
| K243687 | Vital Signs | Oxehealth Ltd | QME | Class II | |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | FRO | Unclassified | |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | HGM | Class II | |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | MWI | Class II | |
| K252526 | Rapid DeltaFuse | Ischemaview, Inc. | LLZ | Class II | |
| K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | QAS | Class II | |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | MQL | Class II | |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf) | Heager GmbH | GEX | Class II | |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co.,Ltd. | FGB | Class II | |
| K244061 | X-Wire Guidewire | Imperative Care Inc. | MOF | Class II | |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona Inc | EBW | Class I | |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | EIH | Class II | |
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision BioLogic Inc. | GGP | Class II | |
| K251404 | Quantra QStat Cartridge | Hemosonics, LLC | QFR | Class II | |
| K251246 | Sparrow Ascent | Spark Biomedical Inc. | PZR | Class II | |
| K243834 | NobelZygoma TiUltra Implant system | Nobel Biocare AB | DZE | Class II | |
| K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | QAI | Class II | |
| K243709 | NeuroEars-Anna™ | Neuroears, Inc. | GWN | Class II | |
| K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | LLZ | Class II | |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics Inc. | KWY | Class II | |
| K252362 | GBrain MRI | Galileo Cds, Inc. | QIH | Class II | |
| K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corp. | KRO | Class II | |
| K252302 | CARTO™ 3 EP Navigation System V8.1 | Biosense Webster Inc | DQK | Class II | |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd | KIF | Class II | |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | SCA | Class II | |
| K251443 | Promo | DRGEM Corporation | IZL | Class II | |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | ReFlow Medical, Inc | DQY | Class II |