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 3377 of 3526

510(k) clearances, page 3377 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792231	Ams Yeast Biochemical Card	Vitek Systems, Inc.	JXB	Class I	1979-12-19
K792226	Cardivan Blood Pressure Monitor	Paramed Technology, Inc.	DRT	Class II	1979-12-19
K791915	White Sealing Cap	Quinton, Inc.	DQO	Class II	1979-12-19
K791843	Poncy Pak	Poncy, Inc.	KGO	Class I	1979-12-19
K792552	Amido Black 10B Stain	Electrophoresis Corp. of America	HZZ	Class I	1979-12-18
K792549	Fat Red 7B Stain Set	Electrophoresis Corp. of America	HYD	Class I	1979-12-18
K792546	Fetal Check	Alta Diagnostics, Inc.	KJR	Class I	1979-12-18
K792502	TENS 4100	Staodynamics, Inc.	GZJ	Class II	1979-12-18
K792497	Volu-Sol Statim Stain	Volu Sol Medical Industries	IAF	Class I	1979-12-18
K792495	Volu-Sol Urinary Sediment Stain	Volu Sol Medical Industries	ICF	Class I	1979-12-18
K792483	Stains, Counterstains & Gen. Purpose	Laboratory Products, Inc.	ICL	Class I	1979-12-18
K792465	Connecticut Diagnostics, Lts. Direct	Connecticut Diagnostics, Ltd.	CIG	Class II	1979-12-18
K792442	Ferritin Radioimmunoassay	Dade, Baxter Travenol Diagnostics, Inc.	DBF	Class II	1979-12-18
K792357	Sterile Impervious Orthopedic Stockin	Alba-Waldensian, Inc.	KKX	Class II	1979-12-18
K792343	Diathermic Snare (Cresent Type)	Mill-Rose Laboratory	GEI	Class II	1979-12-18
K792334	Behindtheear Hear. Aid Mod. 793U,m,uh,mh	Danavox, Inc.	ESD	Class I	1979-12-18
K792328	Stattek Bun	Boehringer Mannheim Corp.	CDN	Class II	1979-12-18
K792316	Trotex II Screw Needle Biopsy Instr. Set	Ursus Konsult AB	GEE	Class I	1979-12-18
K792289	Lipase Test Kit	Mallinckrodt Critical Care	CET	Class I	1979-12-18
K792264	Tobramycin Liquid Control Serum	Hemometrix	LAS	Class I	1979-12-18
K792263	Tobramycin Control Serum	Hemometrix	LAS	Class I	1979-12-18
K792262	Gentamicin Liquid Control Serum	Hemometrix	LAS	Class I	1979-12-18
K792261	Gentamicin Control Serum	Hemometrix	LAS	Class I	1979-12-18
K792260	Amikacin Liquid Control Serum	Hemometrix	LAS	Class I	1979-12-18
K792259	Amikacin Control Serum	Hemometrix	LAS	Class I	1979-12-18
K792236	Hearing Aid, Unitron Model 905H	Unitron Industries, Inc.	ESD	Class I	1979-12-18
K792222	Shiley Low Pressure Thin-Cuffed Trach.	Shiley, Inc.	EQN	Class II	1979-12-18
K792522	Model 980D TENS Neuropacer	Empi	GZJ	Class II	1979-12-13
K792493	Gentle Floss	Paul E. Jaffe, D.M.D.	JES	Class I	1979-12-13
K792474	TENS 4500	Staodynamics, Inc.	GZJ	Class II	1979-12-13
K792427	Perma-Cryl 20	Coe Laboratories, Inc.	EBI	Class II	1979-12-13
K792321	Implantable End. Mush. Tip Leads030-224	Telectronics, Inc.	DTB	Class III	1979-12-13
K792296	Sanitary/ob Pad	American Hospital Supply	HHD	Class I	1979-12-13
K792059	S.f.-P.a.p. Test Counter Immunoelectro	S.F. Biologicals, Inc.	JFH	Class II	1979-12-13
K791890	Continuous Flush Device, Cat. #14-370	Norton Performance Plastics Corp.	KRA	Class II	1979-12-13
K791682	Cleon 720 Large Field Gamma Camera	Union Carbide Corp.	IYX	Class I	1979-12-13
K792383	Kelman Dipstick	V. Mueller O.V. Baxter Healthcare Corp.	HOE	Class I	1979-12-11
K792294	Breast Pad	American Hospital Supply	FRL	Class I	1979-12-11
K792255	Nevyas Autopress Eye Compressor	Keeler Optical Products, Ltd.	LCC	Class II	1979-12-11
K792224	Contact Lenses Made of Polymethylmethacr	Contact Lenses of the Pacific, Inc.	HPX	Unclassified	1979-12-11
K791793	Usci Pressure Gauge	C.R. Bard Inc	DXT	Class II	1979-12-11
K791782	Usci Balloon Dilatation Inflation Dev.	C.R. Bard Inc	DXT	Class II	1979-12-11
K791510	Blue Field Entoptoscope Bfe100	Medical Instrument Research Assoc., Inc.	HLI	Class II	1979-12-11
K792386	Nutra-Ph Instrument Milk	Hospital Products Co.			1979-12-10
K792381	Bongort Odor Barrier Drain	Howmedica Corp.	EXB	Class I	1979-12-10
K792369	Hyperalimentation Dressing Tray	Pharmaseal Div., Baxter Healthcare Corp.	FRG	Class II	1979-12-10
K792365	Bipolar Forceps	Concept, Inc.	JOS	Class II	1979-12-10
K792341	Pentax Flexible Sigmoidoscope Mod. Fs-34	Pentax Precision Instrument Corp.	FAM	Class II	1979-12-10
K792273	Dexide Dis. Prep Sponge W/idex Patient P	Dexide, Inc.	GEC	Class I	1979-12-10
K792271	Dexide Disposable Surgical Scrub Sponge	Dexide, Inc.	GEC	Class I	1979-12-10