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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3324 of 3528

510(k) clearances, page 3324 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802825	Combined Glucose and Bun Standards	Mallinckrodt Critical Care	JIX	Class II	1980-12-11
K802824	Combuned Calcium and Phosphorus Std.	Mallinckrodt Critical Care	JIX	Class II	1980-12-11
K802823	Cholesterol Standards	Mallinckrodt Critical Care	JIT	Class II	1980-12-11
K802822	Paragon Lipoprotein Electro. Reag. Kit	Beckman Instruments, Inc.	JHO	Class I	1980-12-11
K802821	Paragon Hemoglobin Electro. Reag. Kit	Beckman Instruments, Inc.	JBD	Class II	1980-12-11
K802798	Opratex Abdominal Pad	Secol Co.	GDY	Class I	1980-12-11
K802785	Elastic Bandage	Secol Co.	FQM	Class I	1980-12-11
K802777	Argyle Connect Tube-Con & Non	Sherwood Medical Co.	GAZ	Class II	1980-12-11
K802770	Fiber Optic Headlight #60-0766766	Aspen Laboratories, Inc.	FCT	Class II	1980-12-11
K802769	Fiber Optic Headlight #60-0765	Aspen Laboratories, Inc.	FCT	Class II	1980-12-11
K802753	Campylobacter Selective Supplement (Bl.)	Oxoid U.S.A., Inc.	JSK	Class I	1980-12-11
K802742	Sera-Pak Total Protein Reagent	Miles Laboratories, Inc.	GGK	Class I	1980-12-11
K802728	125I-Testosterone Test Set	Wien Laboratories, Inc.	CDZ	Class I	1980-12-11
K802725	Vista 54 Liquid Chromatography Anal. Sys	Varian Assoc., Inc.	KZR	Class I	1980-12-11
K802721	Glycohemoglobin in Whole Blood	Sigma Chemical Co.	LCP	Class II	1980-12-11
K802704	Siam 80-Instantaneous Sonograph W/stor.	Cgr Medical Corp.	IYO	Class II	1980-12-11
K802641	Gammex Surgical Gloves	Ansell, Inc.	KGO	Class I	1980-12-11
K802636	Platelet Counting Kit	Streck Laboratories, Inc.	GKL	Class II	1980-12-11
K802634	Sterigage Eo Ethyl. Oxide Steril. Indic.	Organon LLC	JOJ	Class II	1980-12-11
K802633	Bun/glucose Standards	Gilford Diagnostics	JIX	Class II	1980-12-11
K802632	Albumin/total Protein Standards	Gilford Diagnostics	JIX	Class II	1980-12-11
K802631	Creatinine Standards	Gilford Diagnostics	JIS	Class II	1980-12-11
K802628	Paragon Electrophoresis Lactate Reag.kit	Beckman Instruments, Inc.	CFE	Class II	1980-12-11
K802608	Hematic Blood Mixer	Helmer Labs, Inc.	KSQ	Class I	1980-12-11
K802837	Dr. Michael's Foot Helper	Dr. Michael'S Foot-Care Products	LDQ		1980-12-10
K802833	Tetra Natal-Mat Water Flotation Mat.	Tetra Group U.S.A., Inc.	IKY	Class I	1980-12-10
K802830	Millar Mikro-Tip Catheter Phonotrans	Millar LLC.	DXW	Class II	1980-12-10
K802820	Travenol 24 Hr. Infusor (Elastomeric Pp)	Travenol Laboratories, S.A.	FRN	Class II	1980-12-10
K802814	Orthofix Axialexternal Fixation Sys.	Cintor Orthopaedic Div.	JEC	Class II	1980-12-10
K802810	Hexokinase, Glucose	Beckman Instruments, Inc.	CFR	Class II	1980-12-10
K802795	Orthopedic Padding	Secol Co.	KGX	Class I	1980-12-10
K802792	Cellona	Secol Co.	ITG	Class I	1980-12-10
K802789	Tubular Bandage	Secol Co.	FQM	Class I	1980-12-10
K802784	Elastic Open Weave Bandage	Secol Co.	FQM	Class I	1980-12-10
K802781	Bedding Pads Eggcreate Pads	Leemart Bedding Mfg. Co.	IKY	Class I	1980-12-10
K802780	Jackson Hydro System	S. Jackson, Inc.	FNG	Class II	1980-12-10
K802779	Load Sentinel II, Trans. Elec. Nerve	Powers Medical Systmes	GZJ	Class II	1980-12-10
K802752	Porous, Breathing Tape W/release Liner	Bioadhesive Systems, Inc.	KGX	Class I	1980-12-10
K802743	Ames Sera-Pak Cholesterol Reagent Kit	Miles Laboratories, Inc.	CHH	Class I	1980-12-10
K802741	Centrifichem Comb. Serum-Based Calib.	Union Carbide Corp.	JIX	Class II	1980-12-10
K802740	Fluff Underpad Type Up1001	Bio D Corp.	KME	Class I	1980-12-10
K802730	Fluff Underpad Type Up1002	Bio D Corp.	KME	Class I	1980-12-10
K802724	Ames Sera-Pak Uric Acid Reagent Kit	Miles Laboratories, Inc.	KNK	Class I	1980-12-10
K802702	Neonatal Phototherapy Unit	Ohio Medical Products	LBI	Class II	1980-12-10
K802693	Oreia-Q-Ty, Enzyme Immunoassay	Organon LLC	KLI	Class II	1980-12-10
K802692	Lancer Uric Acid Auto/stat Kit	Sherwood Medical Co.	KNK	Class I	1980-12-10
K802678	Transcutaneous Electric Nerve Stimulator	General Medical Industries, Inc.	GZJ	Class II	1980-12-10
K802661	Liquisol Testosterone Radioimm. Test Kit	Damon Corp.	CDZ	Class I	1980-12-10
K802341	Dioscan	Sonometrics Systems, Inc.	IYO	Class II	1980-12-10
K802250	Dialysis Control Unit-Centry 2000	Cobe Laboratories, Inc.	FKP	Class II	1980-12-10