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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2488 of 3531

510(k) clearances, page 2488 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903463	Ivt Introducer Sheath	Intensive Technology, Inc.	DYB	Class II	1991-01-03
K905667	Lanex Exam Gloves	Mokiem & Julian Industrial Corp.	LYY	Class I	1991-01-02
K905201	Tpn Fluid Transfer Set	Mcgaw, Inc.	LHI	Class II	1991-01-02
K905070	Vistar	Philips North America LLC	LNH	Class II	1991-01-02
K904719	Disposable Face Mask	Tri/Bor Medical, Inc.	BYG	Class I	1991-01-02
K904716	Aero-Gen Nebulizer	Tri/Bor Medical, Inc.	CAF	Class II	1991-01-02
K904715	Oxygen/air Tubing	Tri/Bor Medical, Inc.	CAF	Class II	1991-01-02
K904695	Gdc-1501	Deringer-Ney, Inc.	EJT	Class II	1991-01-02
K904694	Customed Angiodrape Pack Femoral	Customed, Inc	KKX	Class II	1991-01-02
K904693	Customed Cardiovascular Pack	Customed, Inc	KKX	Class II	1991-01-02
K904231	Model Osp, Sandhill Ams	Diversatek Healthcare Inc	FAD	Class II	1991-01-02
K903552	Oral-Cath Suction Catheter	Concord Protex	BSY	Class I	1991-01-02
K903128	Stimtrac Pc, Catalog No. 78-8510	Stimtech Products	GZJ	Class II	1991-01-02
K902691	Doppler Option for Platinum	Philips North America LLC	IYN	Class II	1991-01-02
K901953	Airox Axr. 1A	Ferguson Medical	CBK	Class II	1991-01-02
K896851	Pgr Hip Stem (Endoprosthesis) for Large Bone Resec	Lima Intl. Corp.	JDI	Class II	1991-01-01
K905671	Broda Wheelchair	Broda Ent., Inc.	IOR	Class I	1990-12-31
K905655	Nonabsorbable Polypropylene Surgical Mesh	United States Surgical, A Division of Tyco Healthc	FTL	Class II	1990-12-31
K905576	Lingraphica Visual Language Prosthesis	Tolfa Corp.	ILQ	Class II	1990-12-31
K905299	Romflex Rehabilitation Equipment	Dyna Flex, Intl.	BXB	Class I	1990-12-31
K905271	Pride Spirit	Pride Health Care, Inc.	INI	Class II	1990-12-31
K904795	Facsprep Robotic Sample Preparation System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKH	Class I	1990-12-31
K904560	Valleylab Laparoscopic Handswitch/electrodes	Medtronic, Inc.	GEI	Class II	1990-12-31
K903946	Cool Cast(r)	Hawthorne Products, Inc.	LGF	Class I	1990-12-31
K903117	Orion Sterile or Towels	Orion Life Systems, Inc.	KKX	Class II	1990-12-31
K905684	Alkaline Phosphatase	Amresco, Inc.	CJE	Class II	1990-12-28
K905483	Memorymate Model 8270 Ite Hearing Aid	3M Company	ESD	Class I	1990-12-28
K905203	Coagulation Reference Plasma, Normal	Medical Diagnostic Technologies, Inc.	GIZ	Class II	1990-12-28
K905015	Surgitek Erectek Tm External Erection Device	Surgitek	LKY	Class II	1990-12-28
K905003	Bio-Guard Shave Prep Tray	Network Medical Systems, Inc.	KME	Class I	1990-12-28
K904927	Hennson International Dental Cad/cam System	Hennson Intl., Inc.	ELW	Class II	1990-12-28
K904644	Eurosun Models - Es-2400, Es-Vho and Es-16	Eurosun, Inc.	LEJ	Class II	1990-12-28
K904586	Palex Irrigation Set	Palex Intl. SA	EXD	Class II	1990-12-28
K904557	Microflo	Life-Tech Intl., Inc.	EXY	Class II	1990-12-28
K904545	Force Gsu Tm System and Force Gsu Tm Handset	Medtronic, Inc.	GEI	Class II	1990-12-28
K904472	Glassman Stone Extraction Set	Wilson-Cook Medical Inc.	LQR	Class II	1990-12-28
K904403	Bard Ambulatory Pca Drug Delivery System	C.R. Bard Inc	FRN	Class II	1990-12-28
K903961	Measles Igg Microassay	Diamedix Corp.	LJB	Class I	1990-12-28
K903844	Omnishunt System for Ventricular Shunting	Cordis US Corp.	JXG	Class II	1990-12-28
K903300	Resp-Ez(tm) Respiratory Monitoring Belt	Epm Information Systems, Inc.	BZQ	Class II	1990-12-28
K905697	Powered Ventilator, Lever i/ii, Battlefield Use	ZOLL Medical Corporation	BTL	Class II	1990-12-27
K905592	Affinity Fsh Test System	BD Becton Dickinson Vacutainer Systems Preanalytic	CGJ	Class I	1990-12-27
K905544	Magnesium Reagent	Amresco, Inc.	JGJ	Class I	1990-12-27
K905197	The Bracket Assembly with a Security System	Ormco Corp.	EJT	Class II	1990-12-27
K905147	Adult,sterile,dispos.,nonivas.,blood Press. Cuffs	Hewlett-Packard Co.	DXQ	Class II	1990-12-27
K904997	Abuscreen Online Tm for Opiates	Roche Diagnostic Systems, Inc.	DJG	Class II	1990-12-27
K904680	Theratek Group Exchange Catheter	Dow Corning Wright	MCW	Class II	1990-12-27
K904674	Central Venous Pressure Manometer	Medex, Inc.	KRK	Class II	1990-12-27
K904336	New Cobe Saturation/hematocrit Monitor	Cobe Laboratories, Inc.	GKF	Class II	1990-12-27
K904039	Reflectance Sensor (Rs-10)	Nellcor, Inc.	DQA	Class II	1990-12-27