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 |
|---|---|---|---|---|---|
| DEN240048 | Spur Peripheral Retrievable Stent System | ReFlow Medical, Inc | SEU | Class II | |
| K251344 | OptiMap™ System | Boston Scientific Corporation | DQK | Class II | |
| K250624 | myAir | ResMed Corp | BZD | Class II | |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | QKB | Class II | |
| K250367 | CoLumboX | Smart Soft Healthcare AD | QIH | Class II | |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech,Inc | IZL | Class II | |
| K243949 | OsteoFlo HydroFiber | Surgentec LLC | MQV | Class II | |
| K243716 | Zionic Pro Max (Radiofrequency) | Termosalud S.L. | PBX | Class II | |
| K243378 | Rapid MLS | Ischemaview, Inc. | QIH | Class II | |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care Inc. | NRY | Class II | |
| K242793 | Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. | Shenzhen Insighters Medical Technology Co., Ltd. | EOQ | Class II | |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | FRN | Class II | |
| K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | Opcom Medical Inc. | FGB | Class II | |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | EGS | Class I | |
| K251578 | Beautifil II | Shofu Dental Corp. | EBF | Class II | |
| K251309 | OSSIOfiber® Suture Anchor | OSSIO, Ltd. | MAI | Class II | |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | DQK | Class II | |
| K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia de Materiais Dentários S.A. | NHA | Class II | |
| K250573 | Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M | Olympus Medical Systems Corp. | ODD | Class II | |
| K250475 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) | Ningbo Baichen Medical Devices Co., Ltd | ITI | Class II | |
| K250435 | Dexter L6 System | Distalmotion SA | SDD | Class II | |
| K243777 | Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) | Theodent, LLC | LBH | Class II | |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | Abbott Medical | GXI | Class II | |
| K242820 | Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products Company, LLC | QBD | Class II | |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | EIA | Class I | |
| K242604 | Helios+ UV-C System | Preventamed Technologies, Inc. dba Surfacide Manufacturing | QXJ | Class II | |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | LZO | Class II | |
| K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ | Abbott Medical | OBJ | Class II | |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical, Inc. | QJP | Class II | |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K250778 | Sil-Flow | Dsi Dental Solutions Ltd | EBF | Class II | |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group Ltd. | DFH | Class II | |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Corp. | MAI | Class II | |
| K250446 | Frida™ Anterior Cervical Plate System | Spineup Inc | KWQ | Class II | |
| K250384 | Ipl400 | El Global Trade Ltd. | OHT | Class II | |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | NFO | Class II | |
| K250239 | NeuroMatch | Lvis Corporation | OLX | Class II | |
| K250005 | Clever One | Ewoosoft Co., Ltd | QIH | Class II | |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | JKA | Class II | |
| K243989 | Second Opinion® 3D | Pearl, Inc. | QIH | Class II | |
| K243937 | Accuro 3S | Rivanna Medical, Inc | IYO | Class II | |
| K243474 | MagnetOs MIS | Kuros Biosciences BV | MQV | Class II | |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | FUJIFILM Corporation | FDF | Class II | |
| K243023 | WiZARD 520 Full Face Mask | Wellell Inc. | BZD | Class II | |
| K242594 | Deepecho | Deepecho | IYN | Class II | |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | HAW | Class II | |
| K242545 | RadiForce MX317W-PA | Eizo Corporation | PZZ | Class II | |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | GEH | Class II | |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | MEH | Class II | |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.p.A. | MBH | Class II |