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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3462 of 3526

510(k) clearances, page 3462 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K772364	Auto. Sampling System	Hewlett-Packard Co.	KIE	Class I	1978-01-05
K772359	Pregnancy Test Kit, Answer	Diagnostic Testing, Inc.	LCX	Class II	1978-01-05
K772345	Fluorescein Conjug. Fract. Mono. Anti.	Kallestad Laboratories, Inc.	DCB	Class I	1978-01-05
K772323	Rianen Estriol Ria Kit	New England Nuclear	CGI	Class I	1978-01-05
K772297	Insufflator, Model G100 & 200	Kli	HIF	Class II	1978-01-05
K772258	Clinicard Ck-II	Harleco	CGS	Class II	1978-01-05
K772255	Ceruloplasmin Nephel. Assay	Kallestad Laboratories, Inc.	DDB	Class II	1978-01-05
K772234	Cardiac Output Module-78231C	Hewlett-Packard Co.	DSK	Class II	1978-01-05
K772216	Port-a-Bout 240	Hudson Oxygen Therapy Sales Co.	CAN	Class I	1978-01-05
K772204	Eyeglass Frames	Logo Paris, Inc.	HQZ	Class I	1978-01-05
K772139	Re-Cell Slide Recap	Geometric Data, Div. Smithkline Corp.	JOY	Class II	1978-01-05
K772095	Hemagglutination Inhibition Test	Miles Laboratories, Inc.	DDR	Class II	1978-01-05
K771983	Scalp Vein Set	Berman, Pcp & Consultants, Inc.	FPA	Class II	1978-01-05
K771415	Ria for Serum Thyroxine	Clinical Immuno-Diagnostics	CDX	Class II	1978-01-05
K771786	Cardiac Pulse Generators 5982/5983	Medtronic, Inc.	DXY	Class III	1978-01-04
K771770	Xyrel-Ra Models 5994/5995	Medtronic, Inc.	DXY	Class III	1978-01-04
K771114	Neutrocim	Septodont	EMA	Class II	1978-01-04
K772348	Nebulizer Adapter	Respiratory Care, Inc.	CAF	Class II	1978-01-03
K772324	Wiredriver	American Sterilizer Co.	HSZ	Class I	1978-01-03
K772322	Depilatory, Electronic	Dura Corp., the	KCX	Class I	1978-01-03
K772321	Arthrostress	Mtd, Inc.	JEB	Class I	1978-01-03
K772320	Emergency Cart	Physio Control, Inc.	BZN	Class I	1978-01-03
K772316	Matrix Strip, Dead-Soft	Den-Mat Corp.	DZN	Class I	1978-01-03
K772315	Kwikap	Den-Mat Corp.	EMB	Class I	1978-01-03
K772314	Wedges, Retaining, Matrix	Den-Mat Corp.	DZN	Class I	1978-01-03
K772304	Dental Implant, Carbon Coated Metal	General Atomic Co.	DZE	Class II	1978-01-03
K772300	Dental Chair, Vanguard	Ritter GmbH	KLC	Class I	1978-01-03
K772293	Bone Marrow Biopsy Device	Radiation Development Co., Inc.	GDM	Class I	1978-01-03
K772280	Receptal Ats Mediastinal Liner	Sorensen Research	CAC	Class II	1978-01-03
K772279	Fotofill Dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1978-01-03
K772278	Fotofill Activator Light	Johnson & Johnson Professionals, Inc.	EBZ	Class II	1978-01-03
K772256	Crown & Bridge Alloy	Johnson & Johnson Professionals, Inc.	EJH	Class II	1978-01-03
K772230	Cannula, Perfusion, Fallopian Tube	J. Sklar Mfg. Co., Inc.	LKF	Class II	1978-01-03
K772229	Miniclamps, Stabiliz., Fallopian Tube	J. Sklar Mfg. Co., Inc.	HCZ	Class II	1978-01-03
K772228	Alsite Magnivision	Al Nyman & Son, Inc.			1978-01-03
K772171	Ear Piercing Device	Robert C. Cameron	JYS	Class I	1978-01-03
K772161	Hemodialysis Apparatus	Heald Manufacturing, Inc.	FKQ	Class II	1978-01-03
K772141	Aerosol & Oxygen Masks	B & F Medical Products, Inc.	BYG	Class I	1978-01-03
K772127	Oxygen Mask, Air-Entrainment	Salter Labs	BYF	Class I	1978-01-03
K772126	Temp. Bridge, Posterior 3-Unit	Lee Pharmaceuticals	DYH	Class II	1978-01-03
K772063	Catheter, Intracranial Press. Monitor.	Cordis US Corp.	GWM	Class II	1978-01-03
K772008	Scalp Vein Sets	Suru Chemicals & Pharmaceuticals, Ltd.	FPA	Class II	1978-01-03
K771977	Cardiac Output Computer Model 701	Instrumentation Laboratory Co.	DSK	Class II	1978-01-03
K771972	5Um Filterset with Y-Injection Site	Abbott Medical	FPB	Class II	1978-01-03
K771769	Tinnitus Maskers, Models S564&s574	Vicon Instrument Co.	KLW	Class II	1978-01-03
K771482	Rinse Block Connector	Quinton, Inc.	KDJ	Class II	1978-01-03
K771425	A-V Shunt Extension	Quinton, Inc.	FKN	Class II	1978-01-03
K771422	Patient by-Pass	Quinton, Inc.	FJQ	Class I	1978-01-03
K772307	Pco 2 Electrolyte	Fisher Scientific Company L.L.C.	CHL	Class II	1977-12-22
K772306	125I Digoxin Test Set	Wien Laboratories, Inc.	DPB	Class II	1977-12-22