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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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	2,669

176,466 records, page 746 of 3530

510(k) clearances, page 746 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141700	Papaya Plus, Digital Extraoral Source X-Ray System	Genoray Co., Ltd.	MUH	Class II	2014-10-31
K141660	Nawalution Skin and Wound Cleanser	Nawa Heilmittel GmbH	FRO	Unclassified	2014-10-31
K141570	Implant Studio	3Shape Medical A/S	LLZ	Class II	2014-10-31
K141312	Sterilucent Process Challenge Device	Sterilucent, Inc.	FRC	Class II	2014-10-31
K141207	Novabone Bioactive Strip	Novabone Products, LLC	MQV	Class II	2014-10-31
K141126	Uniever Disposable Spinal Anesthesia Needle	Unisis Corp	BSP	Class II	2014-10-31
K140464	Sterilucent Psd-85 Hydrogen Peroxide Sterilizer	Sterilucent, Inc.	MLR	Class II	2014-10-31
K140293	Touareg Np Closefit Dental Implants System	Adin Dental Implants Systems, Ltd.	DZE	Class II	2014-10-31
K140008	Virtuosaph Plus Endoscopic Vessel Harvesting System	Terumo Cardiovascular Systems Corporation	GEI	Class II	2014-10-31
K142878	IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-10-30
K142869	Premium Surgiclip III	Medtronic, Inc.	FZP	Class II	2014-10-30
K142851	CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens	Unilens Corp., USA	LPL	Class II	2014-10-30
K142443	Site-Rite 6 Ultrasound System with Pinpoint GT Technology	C.R. Bard Inc	IYO	Class II	2014-10-30
K142414	Miltex N-Tralig Intraligamentary Syringe	Integra LifeSciences Corporation	EJI	Class II	2014-10-30
K142372	Pico Way Laser System	Candela Corpation	GEX	Class II	2014-10-30
K142138	ISO-Gard Mask	Teleflexmedical, Inc.	CBN	Class II	2014-10-30
K142078	Velasii Therapy Laser System	Aspen Laser Systems, LLC	ILY	Class II	2014-10-30
K140590	Astroglide Sensual Strawberry	Biofilm, Inc.	NUC	Class II	2014-10-30
K140493	Elia Scl-70S Immunoassay	Phadia AB	LJM	Class II	2014-10-30
K140052	J2i Implant System	KJ Meditech Co., Ltd.	DZE	Class II	2014-10-30
K140051	Kj External Implant System	KJ Meditech Co., Ltd.	DZE	Class II	2014-10-30
K133810	Vc150 Vital Signs Monitor	Innokas Yhtyma	MWI	Class II	2014-10-30
K132853	Novapacs	Novarad Corp.	LLZ	Class II	2014-10-30
K142984	Leo Minor	Sunnex, Inc.	FSY	Class II	2014-10-29
K142864	ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-10-29
K142811	IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-10-29
K142441	cryoICE croablation probe	AtriCure, Inc.	GEH	Class II	2014-10-29
K142245	EpiAccess System	Epiep, Inc.	DYB	Class II	2014-10-29
K142199	Ascendra Balloon Aortic Valvaloplasty Catheter	Edwards Lifesciences LLC	OZT	Class II	2014-10-29
K142150	Ais Modulift Vbr System	Aesculap Implant System, Inc.	MQP	Class II	2014-10-29
K142090	Rebossis	Orthorebirth Co Ltd	MQV	Class II	2014-10-29
K142053	Universal Clamp Spinal Fixation System	Zimmer Spine, Inc.	OWI	Class II	2014-10-29
K142050	Nuvasive Coroent Small Contoured Interbody System	Nu Vasive, Incorporated	ODP	Class II	2014-10-29
K141912	Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon	Advanced Orthopaedic Solutions, Inc.	KTT	Class II	2014-10-29
K141539	Kubtec X250	Kub Technologies, Inc.	IZL	Class II	2014-10-29
K142900	Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh	Sofradim Production	FTL	Class II	2014-10-28
K142884	E-Cube 12	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2014-10-28
K142733	E-Cube 5	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2014-10-28
K142654	Fortrex 0.035 OTW PTA Balloon Catheter	Medtronic, Inc.	LIT	Class II	2014-10-28
K142563	Well Lead PVC Urethral Catheter	Well Lead Medical Co. Ltd	EZD	Class II	2014-10-28
K142170	Bd Phoenix Automated Microbiology Systesm - Tigecycline (0.313-4Ug/ml) Gp	Becton Dickinson & Co	LON	Class II	2014-10-28
K142084	Epi-Sense Guided Coagulation Device with Visitrax	Ncontact Surgical, Inc.	OCL	Class II	2014-10-28
K142082	Zimmer 3.1Mm Dental Implant;2.9mm Angled Abutment;straight Hex, 2.9Mm Contour Abutement	ZimVie US Corp LLC	DZE	Class II	2014-10-28
K142063	#8C Renegade Dental Handpiece	Handpiece Club, LLC	EFB	Class I	2014-10-28
K141713	Smartgraft 200 System	Ingeneron, Inc.	MUU	Class II	2014-10-28
K141686	Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body	Smith Medical Asd, Inc.	DWJ	Class II	2014-10-28
K141459	Aplio 500/400/300 Diagnostic Ultrasound System, V5.0	Toshibamedical Systems Corporation	IYN	Class II	2014-10-28
K141221	Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed Dental Handpieces, Lares Turbo+ Pr	Lares Research	EFB	Class I	2014-10-28
K140383	Allox2 Tissue Expanders	Specialty Surgical Products, Inc.	LCJ	Unclassified	2014-10-28
K140020	Hyperq Acs-100 System	Bsp-Biiological Signal Processing, Ltd.	DPS	Class II	2014-10-28