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 3473 of 3526

510(k) clearances, page 3473 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770857	Dialysis Machine, Centry II	Cobe Laboratories, Inc.	FJF	Class II	1977-10-04
K771775	Colorplast Transverse System	C.R. Bard Inc	EXB	Class I	1977-09-30
K771774	New Base for Orthodontic Appliances	Gac Intl., Inc.	EJF	Class I	1977-09-30
K771765	Myo-Check	Med General	BXN	Class II	1977-09-30
K771764	Coronary Pressure Perfusion Pump	3M Health Care, Sarns	DXS	Class II	1977-09-30
K771750	RF Choke Cable	C.R. Bard Inc	DSA	Class II	1977-09-30
K771739	Pentax Lh-150F Light Source	Pilling Co.	FCW	Class II	1977-09-30
K771673	Catheteo Care Tray #0242	Concord Laboratories, Inc.	FMC	Class I	1977-09-30
K771666	Sphygmomanometer #1235	Sears, Roebuck & Co.	DXG	Class II	1977-09-30
K771659	Patient Restraint System	Mtd, Inc.	FMQ	Class I	1977-09-30
K771640	Suture Clip Remover	United States Surgical, A Division of Tyco Healthc	GDO	Class I	1977-09-30
K771636	Body Restraint	Medical Restraints, Inc.	FMQ	Class I	1977-09-30
K771630	Limb Restraint	Medical Restraints, Inc.	FMQ	Class I	1977-09-30
K771629	Hand Restraint	Medical Restraints, Inc.	FMQ	Class I	1977-09-30
K771515	Suture Tissue Approximating Forcep	United States Surgical, A Division of Tyco Healthc	GEN	Class I	1977-09-30
K771113	Auto Suture R Clip Instrument	United States Surgical, A Division of Tyco Healthc	GAG	Class II	1977-09-30
K771112	Auto Suture R Clip	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1977-09-30
K771007	Electrosurgical Power Generators	Aspen Laboratories, Inc.	GEI	Class II	1977-09-30
K771760	Extemp	Pharmaco, Inc.	GAA	Class I	1977-09-28
K771759	Extemp-V	Pharmaco, Inc.	GAA	Class I	1977-09-28
K771752	Finger Tip Control Pencil	Edward Weck, Inc.	GEI	Class II	1977-09-28
K771751	Disp. Electrosurgery Pencil	Edward Weck, Inc.	GEI	Class II	1977-09-28
K771749	Amalgam Dispenser	New Dimensions in Medicine, Inc.	EHE	Class I	1977-09-28
K771748	Intra Oral X-Ray Cones	General Electric Co.	EAH	Class I	1977-09-28
K771747	Periosteal Elevator	Depuy, Inc.	EMJ	Class I	1977-09-28
K771745	Rasps for Scraping Bone	Depuy, Inc.	HTR	Class I	1977-09-28
K771744	Osteotomes for Cutting Bonh	Depuy, Inc.	HWM	Class I	1977-09-28
K771738	Male Urinal	Bemis Health Care	FNP	Class I	1977-09-28
K771733	8 Emesis Basin	Bemis Health Care	FNY	Class I	1977-09-28
K771732	Thornton Anterior Chamber Irrigator	Concept, Inc.	GBQ	Class I	1977-09-28
K771718	Cardiotherm-500X	Columbus Instruments Intl. Corp.	DXG	Class II	1977-09-28
K771715	Pelvic Wheelchair Restraint	Medical Restraints, Inc.	FMQ	Class I	1977-09-28
K771711	Biotome	Berkeley Bio-Engineering	HQE	Class II	1977-09-28
K771679	Microflator	Fisons Corp.	FLG	Class I	1977-09-28
K771643	Nova 2 Ionized Calcium Analyzer	Nova Biomedical Corporation	JFP	Class II	1977-09-28
K771635	Foot Elevator	Medical Restraints, Inc.	FMQ	Class I	1977-09-28
K771634	Vest Restraint	Medical Restraints, Inc.	FMQ	Class I	1977-09-28
K771632	Finger Mitt Restraint	Medical Restraints, Inc.	FMQ	Class I	1977-09-28
K771594	Primary Piggyback Venoset W/ Filter	Abbott Medical	FPB	Class II	1977-09-28
K771432	Hicaliq Ivh Bag	Terumo America, Inc.	KPE	Class II	1977-09-28
K771431	Artificial K-Nose Breathaid	Terumo America, Inc.			1977-09-28
K771746	Forceps	Depuy, Inc.	GEN	Class I	1977-09-26
K771743	Surg. Scissors for Cutting Tissue	Depuy, Inc.	FZT	Class I	1977-09-26
K771727	Biosponge Reconstruction Discs	Xomed, Inc.	JOF	Class II	1977-09-26
K771726	Biosponge Stapes Piston	Xomed, Inc.	JOF	Class II	1977-09-26
K771725	Biosp. Total Ossicular Replace. Prosthe.	Xomed, Inc.	FEX	Class I	1977-09-26
K771722	Sensomat	Biochem International, Inc.	CCC	Class II	1977-09-26
K771707	Adidyne 3000	Timeter Instrument Corp.	BTI	Class II	1977-09-26
K771688	Echo-Oculometer	Storz Instrument Co.	IYO	Class II	1977-09-26
K771644	Fragmatome Model 820	Berkeley Bio-Engineering	HQC	Class II	1977-09-26