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 3388 of 3526

510(k) clearances, page 3388 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791608	Bilsom Propp	Bilson International, Inc.	EWD	Unclassified	1979-10-10
K791913	Imv Manifold #M-506	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791912	Imv for Monitoring #M-510	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791911	Fall-Safe Imv #M-511	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791910	Three Liter Bag #M-512	Mem Medical, Inc.	BTC	Class I	1979-10-09
K791909	Imv Bushing #M-513	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791908	Retard Valve 3-Stack #M-514	Mem Medical, Inc.	CBP	Class II	1979-10-09
K791907	Retard Valve 3-Stack #M-515	Mem Medical, Inc.	CBP	Class II	1979-10-09
K791906	Imv W/bag #M-507	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791905	Imv W/bag & Tubing #M-508	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791904	Imv W/bag & Hoses #M-509	Mem Medical, Inc.	CBO	Class II	1979-10-09
K791810	Vascular Graft Prost. of Expanded PTFE	Impra, Inc.	DYF	Class II	1979-10-09
K791534	Hollister Urostomy Pouch	Hollister, Inc.	EXB	Class I	1979-10-09
K791434	Sponge Counter Bags	Medicare Industries, Inc.	KDC	Class I	1979-10-09
K791416	Pyrolite Carbon Alveolar Mainten Implant	Carbomedics, Inc.	LYC	Class II	1979-10-09
K791366	Oratronics Endosseous Frame Assembly	Oratronics, Inc.	NRQ	Class II	1979-10-09
K791223	Den-Mat Dental Flosser	Den-Mat Corp.	JES	Class I	1979-10-09
K791154	Thermal Conditioning System	Acurex Aerotherm	IRT	Class II	1979-10-09
K791064	Duo Two Layer Denture Cleanser	Block Drug Company, Inc.	EFT	Class I	1979-10-09
K791987	Vascular Forceps & Clamps	Edward Weck, Inc.	GEN	Class I	1979-10-04
K791986	Fix. & Lens for. #'S 3510,3512,3248,3795	Edward Weck, Inc.	HNR	Class I	1979-10-04
K791985	Hooks #'S 7600,7602,7603,7616	Edward Weck, Inc.	HNQ	Class I	1979-10-04
K791983	Spatula's #'S 7618,7248,7240,7242,5108	Edward Weck, Inc.	HND	Class I	1979-10-04
K791982	Cannula's Cat #'S 6636, 6624, 6625	Edward Weck, Inc.	HMX	Class I	1979-10-04
K791981	Swan Knife Needle 1.5Mm Cat # 1170	Edward Weck, Inc.	HNN	Class I	1979-10-04
K791980	Tome's #'S 1221,1222,1223,1314,6640,6642	Edward Weck, Inc.	HNN	Class I	1979-10-04
K791960	Roth-Kennedy Passer	3M Company	HWQ	Class I	1979-10-04
K791931	Prehensile Hand	Therapeutic Recreation Systems, Inc.	IRA	Class I	1979-10-04
K791919	Bac Jac	Haggin Industries, Inc.	HST	Class I	1979-10-04
K791875	Parke-Davis Total Hip Prosthesis	Warner-Lambert Co.	DXQ	Class II	1979-10-04
K791866	Standard Health Bike Model 019	Battle Creek Equipment	ISD	Class II	1979-10-04
K791862	Heart Rate Computer	Stanford Assoc., Inc.	DRT	Class II	1979-10-04
K791861	Oxygen Hoods	Ann Arbor Plastics, Inc.	FOG	Class I	1979-10-04
K791859	Tecnol Stirrups Strap	Tecnol New Jersey Wound Care, Inc.	BWN	Class I	1979-10-04
K791832	Vein Graft Cannula	D/P, Inc.	DWF	Class II	1979-10-04
K791815	Mueller Hinton Chocolate	Isle Media and Sterile Products, Inc.	JTZ	Class II	1979-10-04
K791786	Salmonella Shigella Agar Plate	American Laboratory Supply, Inc.	JSI	Class I	1979-10-04
K791759	Test Pressure Gauge #6675-32	Depuy, Inc.	KCY	Class I	1979-10-04
K791752	Lectrovac, Valleylab Models	Medtronic, Inc.	GEI	Class II	1979-10-04
K791742	Brooks Gall Bladder Scissors (Surg)	Edward Weck, Inc.	FZT	Class I	1979-10-04
K791741	Floor Line Instruments	Edward Weck, Inc.	FZT	Class I	1979-10-04
K791719	Barrier & Face Mask with Inner Facing	Surgikos, Inc.	KKX	Class II	1979-10-04
K791718	Sears 5 Foot Acrylic Bathtub/whirlpool	Universal-Kundle Corp.	ILJ	Class II	1979-10-04
K791705	4200 Pneumatic Mouth Shutter	Hans Rudolph, Inc.	CCM	Class II	1979-10-04
K791703	Tew Bypass Instruments & Dissecting Kit	Edward Weck, Inc.	GDI	Class I	1979-10-04
K791636	Accunamic	Sorensen Research	DRS	Class II	1979-10-04
K791418	Vasculizer	Diagnostics Intl.	DPW	Class II	1979-10-04
K791304	Howmedica a-30 Dental Alloy	Howmedica Corp.	EJT	Class II	1979-10-04
K791164	Negatove Pressure Convertor	Medicorp, Inc.	FLC	Class II	1979-10-04
K791040	Sector Scanner, Sdu-100, Computerized	Shimadzu Corp.	IYO	Class II	1979-10-04