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 |
|---|---|---|---|---|---|
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co. Ltd. | LPN | Class II | |
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | NGX | Class II | |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | KNW | Class II | |
| K262406 | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific Corporation | FTM | Class II | |
| K262399 | Millipede System | Perfuze | NRY | Class II | |
| K262392 | APRO 35 Swift Catheter | Alembic LLC | DQY | Class II | |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II | |
| K262344 | Large Compression Screws | Trimed Inc | HWC | Class II | |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | LLZ | Class II | |
| K261170 | Ba-004Cc | FUJIFILM Corporation | ITX | Class II | |
| K260944 | ManaCold Compression System | Manamed LLC | IRP | Class II | |
| K260086 | CadAI-B Dx | BeamWorks, Inc. | QDQ | Class II | |
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology, Ltd. | OAB | Class II | |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | MWI | Class II | |
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corp. | CCK | Class II | |
| K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | SBH | Class II | |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co.,Ltd. | GEX | Class II | |
| K261398 | Dexter L6 System | Distalmotion SA | SDD | Class II | |
| K261115 | VR® Personal Protective Level 4 Gown (VR Gowns) | Polyconversions, Inc. | QPC | Class II | |
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | DAP | Class II | |
| K253665 | Vashe Plus Antimicrobial Solution | URGO Medical North America, LLC | FRO | Unclassified | |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | FMI | Class II | |
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | |
| K261602 | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development CO., Ltd | OHS | Class II | |
| K261576 | Icona Hip Stem | Corin Limited | MEH | Class II | |
| K260176 | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K260165 | Unimpregnated Central Venous Catheter | Spectrum Vascular | FOZ | Class II | |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | ITX | Class II | |
| K254069 | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | |
| K254036 | Novii+ Wireless Patch System | GE Healthcare | HGM | Class II | |
| K253794 | Prostate Core | Lucida Medical, Ltd. | QIH | Class II | |
| K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics Inc. | NIG | Class II | |
| K253468 | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) | Nova Eye Inc. | MPA | Class II | |
| K262357 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex GmbH | MAI | Class II | |
| K261937 | PacTemp Automix NE | The Belport Company, Inc dba Gingi-Pak | EMA | Class II | |
| K261905 | BUM Oil | Bumlicious, LLC (dba “Bumlicious”) | NUC | Class II | |
| K261668 | Venue Go | GE Healthcare | IYN | Class II | |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd | OHS | Class II | |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics Inc. | JWH | Class II | |
| K261437 | Mistral-Air® Warming System | The Surgical Company International B.V., doing business as TSC Life | DWJ | Class II | |
| K261362 | Xpert Hemorrhagic Fever | Cepheid | QVR | Class II | |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd | FYA | Class II | |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | FMI | Class II | |
| K260567 | EW10-EC02 Endoscopy Support Program | FUJIFILM Corporation | QNP | Class II | |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | FDS | Class II | |
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | QKQ | Class II | |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | PSY | Class II |