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 |
|---|---|---|---|---|---|
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | Macrolux Medical Technology Co., Ltd. | HIH | Class II | |
| K240740 | qCT LN Quant | Qure.ai Technologies Inc | QIH | Class II | |
| K240573 | iTero Lumina™ Pro | Align Technology, Inc. | NTK | Class II | |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Shenzhen VitaVitro Biotech Co.,Ltd. | MQF | Class II | |
| K240133 | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | NPM | Class II | |
| K240081 | Human Lubricant | Jiangxi Wulinxiang Biological Technology Co., Ltd. | NUC | Class II | |
| K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | Jdentalcare SRL | DZE | Class II | |
| K233755 | HeartKey® Rhythm | B-Secur Limited | DQK | Class II | |
| K233700 | Avicenna Roboflex | Elmed Elektronik ve Medikal Sanayi ve Ticaret Anonim Sirketi | FGB | Class II | |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | LOX | Class II | |
| K231979 | Mecun SpO2 sensor | Shenzhen Mecun Medical Supply Co., Ltd. | DQA | Class II | |
| K223700 | Boss™ | Intelon Optics | MXK | Class II | |
| K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd | NBW | Class II | |
| DEN230090 | First To Know Syphilis Test | Nowdiagnostics, Inc. | SBZ | Class II | |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical Ltd | KNS | Class II | |
| K241810 | MICROLET®NEXT Lancet | Medrad, Inc. | QRK | Class II | |
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate | Zimmer Switzerland Manufacturing GmbH | HRS | Class II | |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | FMK | Class II | |
| K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K241522 | NPseal (20 and 25) | Guard Medical, Inc. | OKO | Class II | |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Corp. | GCJ | Class II | |
| K241211 | CoLumbo | Smart Soft Healthcare | QIH | Class II | |
| K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd | FMF | Class II | |
| K240837 | TOV Dental Implant System | RDJ Tov Implant Ltd | DZE | Class II | |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | ITX | Class II | |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | LOX | Class II | |
| K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | Aicheck Biotech, Inc. | NFT | Class II | |
| K242059 | Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) | X-Cel Specialty Contacts, A Walman Optical Company | LPL | Class II | |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | Halyard Health | GXD | Class II | |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. | NGL | Class II | |
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings dba Intimate Rose | HDX | Class II | |
| K241571 | BostonSight® Specialty Lenses | Boston Foundation for Sight, Inc. D/B/A Bostonsight | HQD | Class II | |
| K241510 | CROSSLEAD Tracker | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K240957 | Catapult Guide Sheath | Contract Medical International GmbH | DYB | Class II | |
| K240713 | Traumagel® | Cresilon Inc | QSY | Unclassified | |
| K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | HFE | Class II | |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.p.A. | CBK | Class II | |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co.,Ltd | LCX | Class II | |
| K241813 | SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System | SI-Technology, LLC | OUR | Class II | |
| K241699 | Super Veloce | Ilooda Co,., Ltd. | GEX | Class II | |
| K241686 | Power wheelchair (N6101) | Zhejiang Zhonglei Medical Technology Co., Ltd. | ITI | Class II | |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1) | Weifang Dragonfly Electronics Technology Co., Ltd. | GEX | Class II | |
| K241429 | ECHELON Synergy MRI System | Fujifilm Healthcare Corporation | LNH | Class II | |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | In2bones USA, LLC | HRS | Class II | |
| K241094 | Bullsai | Turing Medical Technologies, Inc. | LLZ | Class II | |
| K240807 | Vm-2000 | Ventis Medical Inc | CBK | Class II | |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | MOS | Class II | |
| K242054 | OptimMRI (v2) | Rebrain, SAS | QIH | Class II | |
| K241846 | E3D™-C Interbody System | Evolution Spine, LLC | OVE | Class II | |
| K241656 | Eneka Selectif | Termosalud | GEX | Class II |