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 3458 of 3526

510(k) clearances, page 3458 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780092	Ultrachem Albumin	Harleco	CIX	Class II	1978-02-07
K780080	Lactate Dehydrogenase Colorimetric Sub.	Corning Medical & Scientific	CFE	Class II	1978-02-07
K780068	Alp Reagent Set	Medical Analysis Systems, Inc.	CJE	Class II	1978-02-07
K780018	Thyro-Indicator T-3 125I	Clinical Immuno-Diagnostics	CDP	Class II	1978-02-07
K780015	Thyroid Stimulating Hormone	Pcl-Ria, Inc.	JLW	Class II	1978-02-07
K780171	Elbow Protector	Stat Medical Corp.	FMP	Class I	1978-02-06
K780132	Implant, Hinge Toe, Flex.	Dow Corning Corp. Healthcare Industries Materials	KWH	Class II	1978-02-06
K780120	Anesthesia Tray, Caudal	Kendall Research Center	CAZ	Class II	1978-02-06
K772309	Endocardial Pacing Electrode	Coratomic, Inc.	DTB	Class III	1978-02-06
K780142	Anticonvulsant Control Serum	Mcdonnell Douglas Corp.	LAS	Class I	1978-02-03
K780122	Htsh Ria	Abbott Medical	KHO	Class I	1978-02-03
K780117	Cardiometer	Med General	DRT	Class II	1978-02-03
K780016	Human Follicle Stimulating Hormone	Pcl-Ria, Inc.	CGI	Class I	1978-02-03
K772329	Las-R Human Prealbumin Test	Hyland Therapeutic Div., Travenol Laboratories	JZJ	Class I	1978-02-03
K772328	Las-R Human Antithrombin III Test	Hyland Therapeutic Div., Travenol Laboratories	JBQ	Class II	1978-02-03
K772195	Hematology Reference Controls	R & D Systems, Inc.	JPK	Class II	1978-02-03
K772080	Radial Immunodiffusion Kit-Alph-L-Antit	Gelman Instrument Co.	DEM	Class II	1978-02-03
K772079	Radial Immunodiffusion Kit-Immunoglob.m	Gelman Instrument Co.	DFL	Class II	1978-02-03
K772078	Radial Immunodiffusion Kit-Haptoglobin	Gelman Instrument Co.	DAB	Class II	1978-02-03
K772077	Radial Immunodiffusion Kit-Immunoglob.g	Gelman Instrument Co.	DEW	Class II	1978-02-03
K772076	Radial Immunodiffusion Kit-Immunoglob.	Gelman Instrument Co.	CZP	Class II	1978-02-03
K772075	Radial Immunodiffusion Kit-Complement	Gelman Instrument Co.	DAY	Class II	1978-02-03
K772074	Radial Immunodiffusion Kit-Transferrin	Gelman Instrument Co.	DDI	Class II	1978-02-03
K772073	Radial Immunodiffusion Kit-Comp. 3	Gelman Instrument Co.	DBI	Class II	1978-02-03
K780153	House Suction Irrigator	Edward Weck, Inc.	JYC	Class I	1978-02-02
K780152	Facelift Scissors	Edward Weck, Inc.	FZT	Class I	1978-02-02
K780145	Blood Filter, Microemboli-Ats-F10	Sorensen Research	CAK	Class II	1978-02-02
K780134	Urinary Drainage Monitoring System	Medical Devices Inc.	FCN	Class II	1978-02-02
K780133	Muscle Stimulator, Electrical	De Electronics	IPF	Class II	1978-02-02
K780088	Hymidifier	3M Company	BTT	Class II	1978-02-02
K780044	Breathing Circuit, Bain	Respiratory Care, Inc.	CAI	Class I	1978-02-02
K780011	Conchapak Oxygen Diluter	Respiratory Care, Inc.	BYF	Class I	1978-02-02
K772379	Joseph Saw	Edward Weck, Inc.	KBC	Class I	1978-02-02
K772284	Bubble-Type Oxygenator	Cobe Laboratories, Inc.	DTZ	Class II	1978-02-02
K772186	Electrocardiograph Transmitter, 536	Intermedics, Inc.	DXH	Class II	1978-02-02
K771892	Valve Anesthetic	Promed Corp.	CAD	Class II	1978-02-02
K780139	Pneumatic Powered Bur	North Palm Beach Orthodepic Assoc.	HSZ	Class I	1978-02-01
K780065	Ultrachem E-Glu, Manual Determ.	Harleco	CFR	Class II	1978-02-01
K780056	Oxygenator Holder	C.R. Bard Inc	DTL	Class II	1978-02-01
K780042	Hydorrybutyrate Dehydrogenase	Beckman Instruments, Inc.	JMK	Class I	1978-02-01
K780041	Lactate Dehydrogenase	Beckman Instruments, Inc.	CFJ	Class II	1978-02-01
K772414	Sandbags, Various Weights	Fred Sammons, Inc.	IOD	Class I	1978-02-01
K771218	Intra-Articular Shaver	Dyonics, Inc.	KIJ	Class I	1978-02-01
K780136	Collar, Cervical, Split	Richard'S Medical Equip., Inc.	IQK	Class I	1978-01-31
K780135	Cement Extraction Instrument Set	Orthopedic Equipment Co., Inc.	KDG	Class I	1978-01-31
K780128	Blood Pressure Monitor, Arterial	Applied Medical Research	DRS	Class II	1978-01-31
K780127	Dinamap Model 850	Applied Medical Research	DRS	Class II	1978-01-31
K780109	Till-U=test	Clinifax Industries, Ltd.	JXA	Class I	1978-01-31
K780064	Spirometer, Monitoring W/alarm	Ohio Medical Products	BZK	Class II	1978-01-31
K780040	Alanine Transaminase	Beckman Instruments, Inc.	CKA	Class I	1978-01-31