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 2970 of 3529

510(k) clearances, page 2970 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852753	Dc Liquitrol Level 1 & 2	Diagnostic Chemicals, Ltd. (USA)	JJY	Class I	1985-08-02
K852672	Aca Gentamicin Test Pack	E.I. Dupont de Nemours & Co., Inc.	LCD	Class II	1985-08-02
K852649	Pressure Regulator/y Connector	C.R. Bard Inc	CAN	Class I	1985-08-02
K852434	1208 Betacord and 1208 Betcord M	Lkb Instruments, Inc.	JJJ	Class I	1985-08-02
K852415	Titanium Probes	L.A.S.E.R., Inc.	GAD	Class I	1985-08-02
K852306	Replacement Reagents for Smac II Systems	Methodist Hospital of Memphis	JJC	Class I	1985-08-02
K851922	Ureteral Stone Dislodger	Inter-Med, Inc.	FFL	Class II	1985-08-02
K851451	Stat Gas Module	Vulcan Laboratories, Inc.	KLK	Class II	1985-08-02
K850541	Sleep Stager	Oxford Medilog, Inc.	OLT	Class II	1985-08-02
K853073	Culturette Brand 10-Minute Group a Strep I.d.	Marion Laboratories, Inc.	GTZ	Class I	1985-08-01
K853054	RF Card Test	Preco, Inc.	DHR	Class II	1985-08-01
K852933	Mycoplasma Spp Serological Reagents	Microbix Biosystems, Inc.	GSB	Class I	1985-08-01
K852840	Enzyme Antinuclear Antibody Screening Test	Modern Diagnostics, Inc.	LJM	Class II	1985-08-01
K852770	Carioline(electrocardiograph)	Remco Italia S.p.A.	DPS	Class II	1985-08-01
K852758	Infusion Cannulam	Precision Medical Instruments, Inc.	HMX	Class I	1985-08-01
K852234	Mds 83 Ophthalmic Dye Laser System	Meditec Co., Ltd.	HQF	Class II	1985-08-01
K851495	Thoratec Multilumen Central Venous Cath-Tray	Thoratec Laboratories Corp.			1985-08-01
K851456	Accu-Chek II	Boehringer Mannheim Corp.	CGA	Class II	1985-08-01
K844596	Emergency Room & Minor Office Procedure Custom Kit	Xanmed Corp.			1985-08-01
K842814	Permalid Liner Pak	CooperVision, Inc.			1985-08-01
K842781	Permalid Pak	CooperVision, Inc.			1985-08-01
K853082	Ohmeda 5120 Oxygen Monitor	GE Healthcare	CCL	Class II	1985-07-31
K852906	Duraclean Denture Cleaner	Astron Dental Corporation	JER	Class I	1985-07-31
K852814	Glossy Polishing Paste	Scientific Pharmaceuticals, Inc.	EJR	Class I	1985-07-31
K852800	A-Company Self-Ligating Appliance	A Company, Inc.	EJF	Class I	1985-07-31
K852756	Teledyne Getz Barrier-Dentin Sealer	Scientific Pharmaceuticals, Inc.	LBH	Class II	1985-07-31
K852743	Porcelain Veneer System Laboratory Kit	The S. S. White Co.	EIH	Class II	1985-07-31
K852690	Hearing Aid, Unitron Model Um60-H	Unitron Industries, Inc.	ESD	Class I	1985-07-31
K852670	A-Company Espree Safety Headgear	A Company, Inc.	DZB	Class II	1985-07-31
K852600	A-Company Elastomeric Chain Dispenser	A Company, Inc.	ECI	Class I	1985-07-31
K852599	A-Company Elastomeric Tubing	A Company, Inc.	ECI	Class I	1985-07-31
K852598	A-Company Separating Elastics	A Company, Inc.	ECI	Class I	1985-07-31
K852597	A-Company Elastic Rotation Wedges	A Company, Inc.	ECI	Class I	1985-07-31
K852596	A-Company Elastic Ligature Rings	A Company, Inc.	ECI	Class I	1985-07-31
K852548	Atl 225 Mw Trail Lens Set	Ascon Medical Instruments, Ltd.	HPA	Class I	1985-07-31
K852524	Satalec Servotorque S2 Sx2	Spelna, Inc.	EIA	Class I	1985-07-31
K852521	Satlec Prophy Unit Pu 3055	Spelna, Inc.	KOJ	Class II	1985-07-31
K852476	Interplak	Dental Research Corp.	JEQ	Class I	1985-07-31
K852384	Sight Saver All Purpose Lens Carrying Case	Bausch & Lomb Incorporated	HPX	Unclassified	1985-07-31
K852347	Dental Casting Alloy Gdc 1686	Deringer-Ney, Inc.	EJS	Class II	1985-07-31
K852187	Site Infusion Contact Lens W/illuminator	Microsurgical Systems, Inc.			1985-07-31
K852102	Collin Body Plethysmograph Plus System	Warren E. Collins, Inc.	CCM	Class II	1985-07-31
K851929	Restore*	Johnson & Johnson Professionals, Inc.	EBF	Class II	1985-07-31
K851707	Omron Digital Bp Monitor Hem-400C	Omron Tateisi Electronics Co.	DXN	Class II	1985-07-31
K851698	Anne Marie Perris Sunglasses and Frames	Perlinea Co.	HQY	Class I	1985-07-31
K851136	Trophy Compact - Dental Unit	Trophy Radiologie	EIA	Class I	1985-07-31
K851073	Cuprident	Bio Systems, Inc.	EJR	Class I	1985-07-31
K851052	Tubulitec Primer	Dental Therapeutics AB	LBH	Class II	1985-07-31
K843957	Ultrathin/sp Lens	Optical Systems Intl., Inc.	HRG	Class I	1985-07-31
K853011	Bactec Nr-730 Bacterial Detection System	BD Becton Dickinson Vacutainer Systems Preanalytic	JTA	Class I	1985-07-30