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 2026-11-05, 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 2022 of 3531

510(k) clearances, page 2022 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955609	Conveen Urine Bag - Sterile	MEDLINE INDUSTRIES, LP - Northfield	FAQ	Class I	1995-12-29
K955390	Insulin-Like Growth Factor-I (Igf-I) Immunoradiometric Assay	Corning Nichols Diagnostics	CFL	Class I	1995-12-29
K955142	Digital Clinical Thermometer, Models St-823, St-823A, St-813A & St-814A	Salutron, Inc.	FLL	Class II	1995-12-29
K955106	Bte Cpm-20	Baltimore Therapeutic Equipment Co.	BXB	Class I	1995-12-29
K955105	Bte Cpm-10	Baltimore Therapeutic Equipment Co.	BXB	Class I	1995-12-29
K954529	Automated Tru-Cut Biopsy Device	Baxter Healthcare Corporation	KNW	Class II	1995-12-29
K954480	Condensate Collection Kit	Nova-Ventrx	CAI	Class I	1995-12-29
K954446	Augustine Intubation Guide	Augustine Medical, Inc.	CCW	Class I	1995-12-29
K954438	Sunmed's Greenline Fiber Optic Laryngoscope	Rms Div.	CCW	Class I	1995-12-29
K954420	Axsym Digitoxin	Abbott Medical	LFM	Class II	1995-12-29
K953877	Mitek Gii Anchor	Mitek Surgical Products, Inc.	MBI	Class II	1995-12-29
K952320	Pyrilinks-D Assay Kit	Metra Biosystems, Inc.	JMM	Class I	1995-12-29
K951593	Lifepak 11	Physio Control, Inc.	DRO	Class II	1995-12-29
K950856	Zoll Pd2000 Pacemaker/advisory Defibrillator, Model Pd2000, Zoll D2000 Advisory Defibrillator, Model D2000	ZOLL Medical Corporation	DRO	Class II	1995-12-29
K955530	Ranir Hi-Technology Dental Floss	Ranir/Dcp Corp.	EFW	Class I	1995-12-28
K955509	Midas Gold Electroforming System	Austenal, Inc.	EJT	Class II	1995-12-28
K955465	Deguprint	Degussa AG	ELW	Class II	1995-12-28
K955406	Scan White 12 Ml	Vident	ELW	Class II	1995-12-28
K955279	D-Sense	Centrix, Inc.	KLE	Class II	1995-12-28
K954964	Aquacenter 2000 System	Aquarius Medical Corp.	HRX	Class II	1995-12-28
K954915	Flexible Intramedullary Reamer	Zimmer GmbH	HTO	Class I	1995-12-28
K954855	Powder Free Plus Patient Examination Glove	Tillotson Healthcare Corp.	LYY	Class I	1995-12-28
K954641	Endo-Leader	Microsurge, Inc.	OCW	Class II	1995-12-28
K954637	American Dental Products Tissue Conditioner & Temporary Reliner	American Dental Products, Inc.	EBI	Class II	1995-12-28
K954595	Cordis Brite Tip Sheath Introducer	Cordis US Corp.	DYB	Class II	1995-12-28
K954546	Blood Gas Mixture	Liquid Technology Corp.	JIS	Class II	1995-12-28
K954314	Ultrafit Liners	Stahmer Weston Scientific	LYU	Class I	1995-12-28
K954271	Westmed Condesate Collection Trap	Westmed Intl.	CAW	Class II	1995-12-28
K953936	Atlantis	Trophy Radiologie	EAP	Class II	1995-12-28
K953358	Surgeons Glove Powder Free	American Pro Latex, Inc.	KGO	Class I	1995-12-28
K952787	Foam Instrument Guard	Oxboro Medical Intl., Inc.	KCT	Class II	1995-12-28
K952731	Townley All Poly Acetabular Cup	Biologically Oriented Prostheses	JDI	Class II	1995-12-28
K952494	Digital Electronic Wrist Blood Pressure Monitor	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	1995-12-28
K950555	J Single Use Head and Jd Reusable Handle	Micro-Mega Societe Anonyme	EGS	Class I	1995-12-28
K946219	Pop-N-Lok Syringe	Retractable Technologies, Inc.	MEG	Class II	1995-12-28
K945774	Beta Femoral Hip Stem	Wrightmedicaltechnologyinc	JDI	Class II	1995-12-28
K943106	Adult Ventilator	Infrasonics Corp.	CBK	Class II	1995-12-28
K942977	Novoste Pulse Plus Blood Containment Device	Best Vascular, Inc.	DYB	Class II	1995-12-28
K941627	A&d Un-231 Ultrasonic Handy Nebulizer	A & D Corporate	CAF	Class II	1995-12-28
K922601	Futrex-5000A	Futrex, Inc.	DSB	Class II	1995-12-28
K922600	Futrex-5000	Futrex, Inc.	DSB	Class II	1995-12-28
K954275	Mepore Plus (9X15cm)	Scott Health Care	KMF	Class I	1995-12-27
K951910	Odyssey Ho:yag Surgical Laser Systems & Accessories	Xintec Corporation	GEX	Class II	1995-12-27
K955439	The Reel Thing (Modification)	Biomedical Devices, Inc.	GBX	Class I	1995-12-26
K955340	Eurotrol Gas - Ise Control	Direct Solutions	JJS	Class I	1995-12-26
K954918	Combiderm Acd	Convatec, A Bristol-Myers Squibb Co.	KMF	Class I	1995-12-26
K954892	Hytec Automimmune Kit (RF)	Hycor Biomedical	DHR	Class II	1995-12-26
K954891	Hytec Autoimmune Kits (Ss-B)	Hycor Biomedical	LKJ	Class II	1995-12-26
K954890	Hytec Autommune Kit (Ena)	Hycor Biomedical	LLL	Class II	1995-12-26
K954608	Cedia Dau Multi-Dr Calibrator/pri, Sec, Inter, High	Boehringer Mannheim Corp.	DKB	Class II	1995-12-26