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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2831 of 3529

510(k) clearances, page 2831 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864748	Pm-8 Heart Rate Monitor	Pulse Time Products, Ltd.	DRT	Class II	1987-03-20
K864704	Cardian III Cr6a	Cardiac Recorders, Ltd.	DPS	Class II	1987-03-20
K864465	Cardiovit at-6	Schiller, AG	DPS	Class II	1987-03-20
K864318	The Buddy System/health Information System	The Buddy Systems, Inc.	DXN	Class II	1987-03-20
K864316	Target Therapeutics Taper Guide Wire	Target Therapeutics	DQX	Class II	1987-03-20
K864090	Shelf Life Change of Sterile Devices	Utah Medical Products, Inc	DRS	Class II	1987-03-20
K870996	Sewon Dental Flosser	Sewon Industry	JES	Class I	1987-03-19
K870978	T-Tube Inserter	Sur-Med Instruments, Inc.	JYM	Class I	1987-03-19
K870961	Richards External Fixation System	Richards Medical Co., Inc.	KTT	Class II	1987-03-19
K870937	Coat-a-Count Methadone Tkmd1	Siemens Healthcare Diagnostics Inc.	DJR	Class II	1987-03-19
K870936	Coat-a-Count Barbiturates Tkba1 and Tkba5	Siemens Healthcare Diagnostics Inc.	DIS	Class II	1987-03-19
K870935	Coat-a-Count Methaqualone Tkmq1	Siemens Healthcare Diagnostics Inc.	KXS	Class II	1987-03-19
K870908	Steady Resin	Great Lakes Orthodontics, Ltd.	EBI	Class II	1987-03-19
K870879	Alanine Transaminase (Alt) Test Kit	Genetic Systems Corp.	CKA	Class I	1987-03-19
K870875	Coat-a-Count Pcp Kit Number Tkpc1	Siemens Healthcare Diagnostics Inc.	LCN	Class I	1987-03-19
K870868	Easy-Test Uric Acid (Uric) #16606	Em Diagnostic Systems, Inc.	KNK	Class I	1987-03-19
K870809	Mcnealy-Glassman Viscera Retainer #3202/3204/3206	Adept-Med Intl., Inc.	GCZ	Class I	1987-03-19
K870740	Coat-a-Count Cocaine Metabolite Tkcn1 & Tkcn5	Siemens Healthcare Diagnostics Inc.	KLN	Class II	1987-03-19
K870690	Centriprep Concentrator	Amicon, Inc.	JJH	Class I	1987-03-19
K870673	Aca Human Chorionic Gonadotropin (Hcg) Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIT	Class II	1987-03-19
K870600	Soft Ear Stethoscope	Kalajian Ent.	CBG	Class I	1987-03-19
K870158	Stratus Free Thyroxine (Ft4) Fluor. Enzyme Immuno.	American Dade	CEC	Class II	1987-03-19
K870011	Contrasyl Impression Material	Contracap	ELW	Class II	1987-03-19
K865055	Dr.bruno Lange Mini-Hba1 Photometer	Diversa Corp.	GKR	Class II	1987-03-19
K864500	Analytic Technology Endo Analyzer Model 8001	Analytic Technology	LQY	Unclassified	1987-03-19
K863913	The Dpc Coat-a-Count Serum Morphine Ria Kit	Siemens Healthcare Diagnostics Inc.	DOE	Class II	1987-03-19
K863499	Candidate(r) Super	Mercia Diagnostics, Ltd.	LRF	Class II	1987-03-19
K870898	Ultra-Lux Light Source	MEDLINE INDUSTRIES, LP - Northfield	FSW	Class II	1987-03-18
K870896	Notch-Needle, Wescott Style	Ocean Medical Products, Ltd.	GAA	Class I	1987-03-18
K870784	A.t.s. 1500 Tourniquet	Aspen Laboratories, Inc.	KCY	Class I	1987-03-18
K870774	Tru-Stim Muscle Stimulator	Briefcase, Inc.	IPF	Class II	1987-03-18
K870764	Schuknecht Wire Cutting Scissors	Treace Medical, Inc.			1987-03-18
K870763	Super Scissors	Treace Medical, Inc.			1987-03-18
K870760	Bur Brush	Treace Medical, Inc.			1987-03-18
K870539	O.b. Slender Regular Tampon	Personal Products Co.	HEB	Class II	1987-03-18
K870397	Aaron C Size(tm) High Temperature Cautery	Sunkey Medical Manufacturing, Inc.	GEI	Class II	1987-03-18
K870374	Percutaneous Introducer W/side Port 3 Way Stopcock	Daig Corp.	DYB	Class II	1987-03-18
K870211	Bondex* Glass Ionomer Cement	Johnson & Johnson Professionals, Inc.	EMA	Class II	1987-03-18
K864455	The Experimental	Martin H. Kaufmann	EFW	Class I	1987-03-18
K870960	Coag-a-Mate(r) Xc	bioMerieux, Inc.	JPA	Class II	1987-03-17
K870940	Solution Admini. Sets- Alter. Drip Chamber/connec.	Travenol Laboratories, S.A.	FPA	Class II	1987-03-17
K870925	Pad, Bed Linen Protective	Quality Disposables, Inc.	KME	Class I	1987-03-17
K870913	Injection Site #014456-120	Clinical Connections, Inc.	FPA	Class II	1987-03-17
K870912	T-Connectors 014500/014501/014502/014503-120	Clinical Connections, Inc.	FPK	Class II	1987-03-17
K870888	Warm Weigh Model N-10 Infant Scale	Air-Shields, Inc.	FRW	Class I	1987-03-17
K870870	Aztreonam 30 Mcg Susceptibility Disk	bioMerieux, Inc.	JTN	Class II	1987-03-17
K870767	The (Crom) Tester	Twin City Surgical, Inc.	KQW	Class I	1987-03-17
K870750	Keeler Pulsair Non Contact Tonometer	Keeler Instruments, Inc.	HKX	Class II	1987-03-17
K870720	Airlife Arterial Blood Gas Sampling Syringe	American Pharmaseal Div. Ahsc	CBT	Class I	1987-03-17
K870583	Neu-Puls(tens) Model #295	Oms Medico, Inc.	GZJ	Class II	1987-03-17