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 |
|---|---|---|---|---|---|
| K221696 | ReWalk P6.0 | Re Walk Robotics, Ltd. | PHL | Class II | |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | Boston Scientific Corporation | EOQ | Class II | |
| K230308 | Alma Harmony | Alma Lasers Ltd. | GEX | Class II | |
| K230283 | Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) | Abbott Medical | DYB | Class II | |
| K223423 | 32Hq713d | LG Electronics.Inc | PGY | Class II | |
| K223144 | Galaxy System | NOAH MEDICAL Corp. | EOQ | Class II | |
| K223040 | Endo SmartCap | Medivators Inc | FAJ | Class II | |
| K222975 | Advantis Platform | Advantis Medical Imaging Single Member P.C. | LLZ | Class II | |
| K222280 | Bigfoot Unity® Diabetes Management System | Bigfoot Biomedical, Inc. | QLG | Class II | |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | KTI | Class II | |
| K221680 | Xeleris V Processing and Review System | GE Healthcare | LLZ | Class II | |
| K221053 | Magnes-C Anterior Cervical Plate System | Fellowship of Orthopaedic Researchers, Inc. | KWQ | Class II | |
| K220014 | Rshock | Swims America Corp | PBX | Class II | |
| K213898 | ProTrack Pigtail Wire | Baylis Medical Co., Inc. | DQX | Class II | |
| K230248 | Viola | Vascular Graft Solutions | DXC | Class II | |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | Guangzhou Decheng Biotechnology Co., Ltd. | LCX | Class II | |
| K223618 | IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K223392 | REVCON (TM) Screw System | Voom Medical Devices, LLC | HWC | Class II | |
| K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | NEY | Class II | |
| K223116 | 8X-10-6XXX Camera Head | Santa Barbara Imaging Systems | GCJ | Class II | |
| K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K222481 | PuraStat | 3-D Matrix, Inc. | QAU | Class II | |
| K222240 | Explorer Air® II | Surgvision GmbH | IZI | Class II | |
| K221790 | HARMONIC 700 Shears | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | QHA | Class II | |
| K221705 | U2 Total Knee System-PF+ | United Orthopedic Corp. | MBH | Class II | |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | Terragene LLC | FRC | Class II | |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | NQQ | Class II | |
| K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | ARUM DENTISTRY Co., Ltd. | EIH | Class II | |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | LPH | Class II | |
| K223075 | Ogmend® Implant Enhancement System | woven Orthopedic Technologies | QVI | Class II | |
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | OCX | Class II | |
| K220035 | Milli Vaginal Dilator | Materna Medical | HDX | Class II | |
| K211181 | Idylla MSI Test | Biocartis NV | PZJ | Class II | |
| K213431 | Handheld Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | DQA | Class II | |
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | FMF | Class II | |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | EOX | Class II | |
| K230205 | Veloxion System | Corinth Medtech, Inc. | FJL | Class II | |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | Clinical Innovations, LLC | FMK | Class II | |
| K223884 | ELITONE Urge Urinary Incontinence Device | Elidah | QAJ | Class II | |
| K223852 | VySpan™ PCT System | VY Spine, LLC | NKG | Class II | |
| K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Sb-Kawasumi Laboratories, Inc. | JKA | Class II | |
| K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | GCJ | Class II | |
| K223582 | MectaLock TI Triple Loaded Suture Anchor | Medacta International SA | MBI | Class II | |
| K223231 | Ti-Largo Cervical Interbody System | Flospine LLC | ODP | Class II | |
| K222757 | Clarus Viewer | Clarus Viewer Corporation | LLZ | Class II | |
| K222386 | Visionbody | Vb Technologies AG | NGX | Class II | |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | Blue Sky Bio, LLC | NXC | Class II | |
| K221614 | TytoCare Lung Sounds Analyzer | Tyto Care Inc. | PHZ | Class II |