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 |
|---|---|---|---|---|---|
| K162667 | Kitazato IUI Catheter | Kitazato Corporation | MQF | Class II | |
| K162566 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | MQX | Class II | |
| K162328 | Winner Transfer Wheelchair | Winner SG Pte, Ltd. | IOR | Class I | |
| K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | UG Global Resources Sdn Bhd | LYY | Class I | |
| K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc | DPS | Class II | |
| K171097 | MOJAVE Expandable Interbody System | K2M, Inc | MAX | Class II | |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | CJE | Class II | |
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix SRL | KTT | Class II | |
| K170594 | I.B.S. osteosynthesis screws | In2Bones SAS | HWC | Class II | |
| K163476 | Lubricity | You First Services, Incorporated | LFD | Unclassified | |
| K162348 | ABCcolla Collagen Matrix | Acro Biomedical Co., Ltd. | KGN | Unclassified | |
| K162125 | MALUC™ Total Hip Arthroplasty System | Surgtech, Inc. | JDI | Class II | |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | FUJIFILM Healthcare Americas Corporation | KGE | Class II | |
| K171081 | Guider Catheter Introducer | Rhythm Xience, Inc. (Rxi) | DYB | Class II | |
| K171022 | Ablation Confirmation | Neuwave Medical, Inc. | JAK | Class II | |
| K170831 | EpiAccess System | Epiep, Inc. | DYB | Class II | |
| K170469 | NxStage System One Plus | NxStage Medical Inc | KDI | Class II | |
| K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | Zibo Chengxun Automatic Device Co., Ltd | LZA | Class I | |
| K170342 | Ocata Anterior Cervical System | Kalitec Direct, LLC | KWQ | Class II | |
| K163606 | Digital Blood Pressure Monitor-Automatic Upper Arm Style | Shenzhen Combei Technology Co.,Ltd. | DXN | Class II | |
| K163382 | Oxitone 1000 | Oxitone Medical, Ltd. | DQA | Class II | |
| K163117 | Alpha Pure | Koroad America | NJM | Class II | |
| K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | BZK | Class II | |
| K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | GEI | Class II | |
| K170771 | VariAx 2 Foot System | Stryker Corp. | HRS | Class II | |
| K170744 | Adhesive Electrodes | Reno Medical, Ltd. | GXY | Class II | |
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | FGE | Class II | |
| K170734 | Venus Silk.expert | Cyden Limited | GEX | Class II | |
| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | OMC | Class II | |
| K170180 | Will3D | HDX Will | LLZ | Class II | |
| K170111 | Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 | Pulsaderm, LLC | OLP | Class II | |
| K163670 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | OVD | Class II | |
| K163327 | Precifit Medical Kirschner Wires | Precifit Medical, Ltd. | HTY | Class II | |
| K162734 | CreoDent Solidex Customized Abutment | Creodent Prosthetics Ltd | NHA | Class II | |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes (USA) Products LLC | MQN | Class II | |
| K161938 | Fingertip Pulse Oximeter | Xuzhou Yongkang Electronic Science Technology Co., Ltd | DQA | Class II | |
| K151562 | Resultz Lice & Egg Removal Kit | Piedmont Pharmaceuticals, LLC | LJL | Class I | |
| K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System | Orthofix SRL | NKB | Class II | |
| K171076 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | FGB | Class II | |
| K170789 | In Reach | CurveBeam, LLC | JAK | Class II | |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | LENSAR, Inc | OOE | Class II | |
| K170475 | SICAGE™ System | Sicage, LLC | OUR | Class II | |
| K170152 | Polychloroprene Powder Free Surgical Glove (Green) | Hartalega Sdn Bhd | KGO | Class I | |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | ILY | Class II | |
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | Nanova Biomaterials Inc | MAI | Class II | |
| K163665 | MATRx plus | Zephyr Sleep Technologies | MNR | Class II | |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | Phadia AB | DHB | Class II | |
| K163315 | Internal Distraction - Sterile | KLS-Martin L.P. | PBJ | Class II | |
| K163293 | Colink™ Plating System | In2bones USA, LLC | HRS | Class II |