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 |
|---|---|---|---|---|---|
| K231337 | EndeavorRx | Akili Interactive Labs, Inc. | QFT | Class II | |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | KLE | Class II | |
| K230964 | Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Co. | GGP | Class II | |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent Inc | PNZ | Class II | |
| K233684 | TriALTIS™ Spine System | Medos International SARL | NKB | Class II | |
| K233646 | Intri24 Introducer Sheath (52-101) | Inari Medical, Inc. | DYB | Class II | |
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | Boston Scientific Corporation | FGB | Class II | |
| K233634 | TeleScan | Bb Imaging | LLZ | Class II | |
| K233455 | ARx MIS Spinal Screw System | Life Spine | NKB | Class II | |
| K233222 | Aygün Sterilization Container Systems | Aygun Surgical Instruments Co.,Inc. | KCT | Class II | |
| K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | FMI | Class II | |
| K232947 | SIRA™ RFA Electrosurgical Device | Innoblative Designs, Inc. | GEI | Class II | |
| K232451 | Insulia Bolus Companion | Voluntis | NDC | Class II | |
| K232425 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | |
| K231669 | Ziehm Solo FD | Ziehm Imaging GmbH | OWB | Class II | |
| K230872 | Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Shanghai Sanyou Medical Co. Ltd | MAX | Class II | |
| DEN230027 | NaviCam ProScan | Ankon Technologies Co., Ltd. | QZF | Class II | |
| K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | PGY | Class II | |
| K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | DRA | Class II | |
| K232985 | 24Hr513c | LG Electronics.Inc | PGY | Class II | |
| K232815 | Wrist Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. | DXN | Class II | |
| K232797 | Hygenix | Shenzhen Hygenix Industrial Co., Ltd. | FXX | Class II | |
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology | Depuy Ireland UC | MBH | Class II | |
| K232290 | INTELLIO SHIFT System | ArthroCare Corporation | GEI | Class II | |
| K232096 | Transpara Density 1.0.0 | Screenpoint Medical | QIH | Class II | |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | DHA | Class II | |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | ELC | Class II | |
| K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | STERIS Corporation | JOJ | Class II | |
| K233432 | 10F Sheath and Dilator Set | Argon Medical Devices, Inc | DYB | Class II | |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | JDI | Class II | |
| K232830 | Vibrant System | Vibrant Ltd | QTN | Class II | |
| K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, S.L. | NHA | Class II | |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port | Bard Peripheral Vascular Inc | LJT | Class II | |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | Shenzhen Kentro Medical Electronics Co., Ltd | NUH | Class II | |
| K232515 | Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | HRS | Class II | |
| K232085 | Dvas (Dvas-M, Dvas-W) | Genoray Co., Ltd. | EHD | Class II | |
| K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | DXN | Class II | |
| K231964 | Novii+ Wireless Patch System | GE Healthcare | HGM | Class II | |
| K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | LLZ | Class II | |
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Corelink, LLC | MAX | Class II | |
| K231061 | NeuroBlate System | Monteris Medical Corp | GEX | Class II | |
| K230722 | Eagle device | Belkin Vision Ltd. | HQF | Class II | |
| K223757 | Bonelogic | Disior Oy | QIH | Class II | |
| K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio de Produtos Medicinais | NPK | Class II | |
| K233429 | Ots 25 (100-1) | Ots-Medical | MBI | Class II | |
| K232846 | Light Based Hair Removal Device | Shenzhen Meik Beauty Industry Co., Ltd. | OHT | Class II | |
| K232795 | Led Mask Platinum Exclusive MD | Stg24 Co., Ltd. | OHS | Class II | |
| K232761 | ProNephro AKI™ (NGAL) | Bioporto Diagnostic, Inc. | PIG | Class II | |
| K232661 | Myocardial Strain Software Application | Circle Cardiovascular Imaging Inc | LLZ | Class II |