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 2982 of 3529

510(k) clearances, page 2982 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851948	Medtronic Model 6404	Medtronic, Inc.	DYG	Class II	1985-06-20
K851940	Sterile Water for Inhalation Usp 2D0799	Travenol Laboratories, S.A.	BTT	Class II	1985-06-20
K851803	71-100 to 71-130 Various Sterilizing Drums	Artiberia			1985-06-20
K851802	69-140 to 69-160 Various Nail Cutters	Artiberia	LRW	Class I	1985-06-20
K851801	69-120 to 69-132 Various Nail Scissors	Artiberia	LRW	Class I	1985-06-20
K851800	69-100 to 69-114 Various Cuticle Scissors	Artiberia	HRR	Class I	1985-06-20
K851796	51-210 to 51-352 Various Intest for Callis, Lockwo	Artiberia	GEN	Class I	1985-06-20
K851793	39-260 to 39-299 Various Foreign Body Forceps	Artiberia	GEN	Class I	1985-06-20
K851789	29-200 to 29-230 Various Bone Mallets(wihiger, Doy	Artiberia	GFJ	Class I	1985-06-20
K851788	29-140 to 29-196 Various Bone Chisels (Osteotomes,	Artiberia	FZO	Class I	1985-06-20
K851787	27-100 to 29-130 Various Bone Saws-Charriere, Satt	Artiberia	GDR	Class I	1985-06-20
K851784	27-210 Plaster Knife (Reiner)	Artiberia	EMF	Class I	1985-06-20
K851783	27-100 to 27-180 Various Plaster Scissors/shears	Artiberia			1985-06-20
K851782	25-450 to 25-540 Various Suture Forceps	Artiberia	GDL	Class I	1985-06-20
K851781	25-420 to 25-436 Various Types of Suture Needles	Artiberia	GDL	Class I	1985-06-20
K851780	25-230 to 25-390 Various Needle Holders	Artiberia	FHQ	Class I	1985-06-20
K851779	25-100,25-220 Various Needle Holders	Artiberia	FHQ	Class I	1985-06-20
K851778	23-130 to 23-144 Two Types of Directors	Artiberia			1985-06-20
K851777	23-100 to 23-124 Various Types of Probes	Artiberia			1985-06-20
K851776	21-450 Gelpi Retractor	Artiberia	GAD	Class I	1985-06-20
K851774	17-900 to 17-980 Various Towel Clamps	Artiberia	GDJ	Class I	1985-06-20
K851773	17-280,17-576 Haemostatic Forceps Spenceruells, Ki	Artiberia	GEN	Class I	1985-06-20
K851772	17-100,17-272 Various Haemostatic Forceps	Artiberia	GEN	Class I	1985-06-20
K851771	15-490 to 15-520 Various Splinter Forceps Peet, St	Artiberia	GEN	Class I	1985-06-20
K851770	Various Dressing Tissue Froceps(gillies, Jeans, Ra	Artiberia	HTD	Class I	1985-06-20
K851769	Various Dressing/tissue Forceps(english, Thumb, Tr	Artiberia	HTD	Class I	1985-06-20
K851768	13-550,13-560 Wescott Scossors (Eye)	Artiberia	HNF	Class I	1985-06-20
K851767	13-530 to 13-542 Various Iris Scissors	Artiberia			1985-06-20
K851766	13-470 to 13-518 Various Uterine Scissors	Artiberia			1985-06-20
K851765	13-440 to 13-464 Various Dissecting Scissors	Artiberia			1985-06-20
K851764	13-340,13-350,13-360 Ligature Scissore Spencer/lit	Artiberia			1985-06-20
K851762	13-290 Various Tonsil Scissors-Strully, Yankauer,	Artiberia			1985-06-20
K851761	13-280 Neuro Scissors	Artiberia			1985-06-20
K851760	13-270 Kilner Scissors	Artiberia			1985-06-20
K851759	13-260 Two Sizes of Joseph Scissors	Artiberia			1985-06-20
K851758	13-224 to 13-258 Various Metzenbaum Scissors	Artiberia			1985-06-20
K851757	13-220 Tow Types of Lexer Scissors	Artiberia			1985-06-20
K851756	13-180 to 13-212 Various Models of Mayo Scissors	Artiberia			1985-06-20
K851755	13-170 Deaver Scissor, Two Sizes	Artiberia			1985-06-20
K851754	13-160 Incision Scissors, Two Sizes	Artiberia			1985-06-20
K851753	13-100 to 13-158 Various Types of Operating Scisso	Artiberia			1985-06-20
K851752	9-190,9-200,9-210,9-220 Amputation Knives, Various	Artiberia	GDN	Class I	1985-06-20
K851751	7-120, 7-130,7-140, 7-150,9-151 to 168, 9-171 to 1	Artiberia	GDX	Class I	1985-06-20
K851750	7-103, 7-104, 7-107 Scalpel Handles, #3 #4 #7	Artiberia	GDZ	Class I	1985-06-20
K851655	Teacher Tm	Monargue Intl.	LRA	Unclassified	1985-06-20
K851392	Tracor 200 Microprocessor Audiometer/tracor Ra 200	Tracor Instruments, Inc.	EWO	Class II	1985-06-20
K851080	Gv Medical, Inc. Lastac Balloon Dilatation Cathete	G V Medical, Inc.	LIT	Class II	1985-06-20
K851030	Temrex-Dentin Varnish	Temrex Corp.	LBH	Class II	1985-06-20
K852123	Wholey Hi-Torque Guide Wires	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1985-06-19
K852104	Manan Ptc Biopsy Trays	Manan Manufacturing Co., Inc.			1985-06-19