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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2681 of 3530

510(k) clearances, page 2681 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K885071	Coat-a-Count Methamphetamin #Tkma1	Siemens Healthcare Diagnostics Inc.	LAF	Class II	1989-01-09
K885025	Houva II Uva	National Biological Corp.	FTC	Class II	1989-01-09
K884847	Mtd Hedrest	Composites Horizons, Inc.	IWY	Class I	1989-01-09
K884562	Oxymatic-24	Chad Therapeutics, Inc.	NFB	Class II	1989-01-09
K884499	Latex Surgical Gloves	Yuli Corp., Inc.	KGO	Class I	1989-01-09
K884463	Connecta Monoflo & Multiflo Infusion Connectors	GE Healthcare	FMG	Class II	1989-01-09
K884335	Gauze Bandage 4 X 6 Yds.	North Health Care	NAB	Class I	1989-01-09
K884334	Gauze Bandage 1 X 6 Yds.	North Health Care	NAB	Class I	1989-01-09
K884333	Gauze Bandage 2 X 6 Yds.	North Health Care	NAB	Class I	1989-01-09
K884293	J-Tip Injector System	California Medical Innovations, Inc.	KZE	Class II	1989-01-09
K884269	Sample Identification Station Model 38010	Icn Micromedic Systems	JJJ	Class I	1989-01-09
K883580	Universal Abc Controler	Philips North America LLC	JAA	Class II	1989-01-09
K882936	Adjustable Entrainment Nebulizer	Automatic Liquid Packaging, Inc.	CAF	Class II	1989-01-09
K882564	Renalin Cold Sterilant	Medivators Inc	LRJ	Class I	1989-01-09
K885172	Additional Electrosurgical Ground Pads	Conmedcorp	GEI	Class II	1989-01-06
K884677	Mam Ls-3 Microfocus Mammography System W/magnifi.	Elscint, Inc.	IZH	Class II	1989-01-06
K884676	Mam-2 Microfocus Mammography System W/magnifi.	Elscint, Inc.	IZH	Class II	1989-01-06
K884012	Mmac II Tonometer	Professional Technologies Corp.	HKX	Class II	1989-01-06
K883469	Bard(r) Aspiration Biopsy System	C.R. Bard Inc	KNW	Class II	1989-01-06
K881664	Latex Surgical Glove	Lien Chang Rubber Industrial Co., Ltd.	KGO	Class I	1989-01-06
K884919	Disposable Dome Stock #D-300	Advanced Medical, Inc.	DRS	Class II	1989-01-05
K884813	Model 200A Electronic Force-Sensing Probe	Vine Valley Research	EIL	Class I	1989-01-05
K884682	Living Technology Laser Contact Tips	Living Technology, Inc.	GEX	Class II	1989-01-05
K884386	Administration/manometer Set W/3 Way Stopcock	Ethitek Pharmaceuticals Co.	KRK	Class II	1989-01-05
K884337	Micro-Guide System	Catheter Research C/O Burditt, Bowles & Radzius	DRA	Class II	1989-01-05
K884330	Model 463 Electrocardiorecorder Recorder	Del Mar Avionics	DSH	Class II	1989-01-05
K884306	Bicap Ablating Forceps Baf-7	Circon Acmi	KNS	Class II	1989-01-05
K883785	Gy-Ro Safe	Gy-Ro Industry, Inc.	HOG	Class I	1989-01-05
K883224	Unna Boot Dressing W/calamine	Graham-Field, Inc.	FRO	Unclassified	1989-01-05
K882977	Ask-300	Medical Repackers Co.	DQR	Class II	1989-01-05
K885074	Affinity(tm) Ferritin Immunit(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	DBF	Class II	1989-01-04
K885065	Ige Fastscreen S6 (F1, F2, F4, F13, F14)	3M Company	DHB	Class II	1989-01-04
K885056	Twixel(tm)	Fouts Development, Inc.	JES	Class I	1989-01-04
K884770	Oncoprobe System	Care Wise Medical Products Corp.	IZD	Class I	1989-01-04
K884766	Berichrom(r) Plasminogen	Behring Diagnostics, Inc.	DDX	Class I	1989-01-04
K884754	Voyager/x	Smith-Perry Corp.	NFB	Class II	1989-01-04
K884381	Palgaflex and Palgaflex-Quick	Espe GmbH (US)	ELW	Class II	1989-01-04
K884245	Perfect Choice	Challenge Products, Inc.	EJK	Class II	1989-01-04
K883940	Ortho* Rotavirus Latex Agglutination Test	Ortho Diagnostic Systems, Inc.	LIQ	Class I	1989-01-04
K883935	Ortho* Rotavirus Antigen Elisa Test	Ortho Diagnostic Systems, Inc.	LIQ	Class I	1989-01-04
K882604	Pulmo-Patty	Tower Stopper, Inc.	BYI	Class II	1989-01-04
K884936	Alanine Aminotransferase	Catachem, Inc.	CKA	Class I	1989-01-03
K884909	Glucose Liquid Amresco #4628300 & 4628001L	American Research Products Co.	CGA	Class II	1989-01-03
K884736	Glucose-Hk Test (Gluc-Hk) Item #65665	Em Diagnostic Systems, Inc.	CFR	Class II	1989-01-03
K884681	Unirest Lc Paint-on Restorative & Veneer Cement	Scientific Pharmaceuticals, Inc.	EBF	Class II	1989-01-03
K884595	Ophthascan Mini-B	Biophysic Medical, Inc.	IYO	Class II	1989-01-03
K884575	Maxibond	Ortho Source	DYH	Class II	1989-01-03
K884391	Premet, Metal Primer	Scientific Pharmaceuticals, Inc.	EBF	Class II	1989-01-03
K884350	Unirest Composite Restorative, Self Cured	Scientific Pharmaceuticals, Inc.	EBF	Class II	1989-01-03
K884288	Hearing Aid, Unitron Bte Model Um60-Agc0	Unitron Industries, Inc.	ESD	Class I	1989-01-03