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 3381 of 3526

510(k) clearances, page 3381 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792199	Unifocal 2-Unipolar & Bipolar	American Pacemaker Corp.	DXY	Class III	1979-11-27
K792198	Series S (Behind-the-Ear-Hearing Aid)	Maico Hearing Instruments, Inc.	ESD	Class I	1979-11-27
K792188	Tetrabead - 125 T4 Solid Phase Diag. Kit	Abbott Medical	CDX	Class II	1979-11-27
K792159	Fisch Drill System	JEDMED Instrument Company	ERL	Class II	1979-11-27
K792155	Co 2 Meter	Boehringer Laboratories, LLC	CCK	Class II	1979-11-27
K792122	Chronaerobic (Ca-1)	Stanford Scientific, Inc.	DRT	Class II	1979-11-27
K792061	Cordia RF	Cordis US Corp.	DHR	Class II	1979-11-27
K792003	1 Step	Betta Dental, Inc.	DYH	Class II	1979-11-27
K791955	Unifocal 1 Unipolar Demand R Wave	American Pacemaker Corp.	DXY	Class III	1979-11-27
K791922	Harleco Brand Clinicard Lipase Test Set	Dade, Baxter Travenol Diagnostics, Inc.	CET	Class I	1979-11-27
K791756	Vdc	Life Sciences Manufacturing, Inc.	DXG	Class II	1979-11-27
K791602	Sci-Pharm Polifil Anterior Restorative	Scientific Pharmaceuticals, Inc.	EBF	Class II	1979-11-27
K791419	Omnicor Programmer Model 222C	Cordis US Corp.	KRG	Class III	1979-11-27
K791284	Anti-Human Kappa Serum	Diagnostica, Inc.	DFH	Class II	1979-11-27
K791283	Anti-Human Lambda Serum	Diagnostica, Inc.	DEH	Class II	1979-11-27
K791281	Anti-Human Igg Serum	Diagnostica, Inc.	DEW	Class II	1979-11-27
K792312	Heart Rate Monitor Md-1	Medical Devices Inc.	DRT	Class II	1979-11-21
K792311	Medtronic Model 7728 Neuromod	Medtronic, Inc.	GZJ	Class II	1979-11-21
K792283	Esophageal ECG Preamplifier & Signal Con	Arzbaecher & Co.	DRR	Class II	1979-11-21
K792246	Medtronic Model 9408 Teletrace Transmit	Medtronic, Inc.	DXH	Class II	1979-11-21
K792229	Electrocardiograph, Model ECG-5151	Nihon Kohden America Inc	DPS	Class II	1979-11-21
K792206	Medtronic Burr Hole Plug & Cap	Medtronic, Inc.			1979-11-21
K792190	Model Cf-300 Three Channel Flow Meter	Wilton Webster Laboratories	DRQ	Class II	1979-11-21
K792070	Sarns Mediastinal and Pericardial Tube	3M Health Care, Sarns	DWF	Class II	1979-11-21
K791559	Roche Sensor Adaptor	Roche Medical Electronics, Inc.	KLK	Class II	1979-11-21
K792210	Gdc 802-Development Name	Deringer-Ney, Inc.	EJT	Class II	1979-11-20
K792202	Trocar Catheter/thoracic Catheter	Abbott Medical	DWF	Class II	1979-11-20
K792194	Vita-Stat Model 900-S	Vita-Stat Medical Services, Inc.	DXN	Class II	1979-11-20
K792193	Vita-Stat Model 900-D	Vita-Stat Medical Services, Inc.	DXN	Class II	1979-11-20
K792101	Couiter/cms Isotonic Blood Bank Saline	Coulter Electronics, Inc.	JCE	Class I	1979-11-20
K792095	Histo-Center II	Thermolyne Corp.	IDW	Class I	1979-11-20
K792065	Porous Elastic Rubber Bandage	Norman R. Sanborn Co.	FQM	Class I	1979-11-20
K792063	Follicle Stimulating Hormone (Fsh) Kit	Cis Radiopharmaceuticals, Inc.	CGJ	Class I	1979-11-20
K792049	i.v. Strip	E-Med Corp.	KMK	Class I	1979-11-20
K792008	Howmedica Ag-Pd Crown and Bridge Alloy	Howmedica Corp.	EJS	Class II	1979-11-20
K791973	Howmedica a-35 Dental Alloy	Howmedica Corp.	EJS	Class II	1979-11-20
K791771	Oraluminator III Auto-Light	Midwest	EAY	Class I	1979-11-20
K791726	Hydrogel-Prep	Spenco Medical Corp.	NAB	Class I	1979-11-20
K791524	Visalens Concentrated Cleaner Cont Lens	Pfizer Inc	HPX	Unclassified	1979-11-20
K792211	Speciman Cup & Emesis Basin	General Clinical Plastics Corp.	FMH	Class I	1979-11-16
K792195	Deodorant Carefree Panty Shields	Personal Products Co.	HHL	Class II	1979-11-16
K792174	Model Dm 353 & Dm-353-L Single Needle	Extracorporeal Medical Specialities, Inc.	FIF	Class II	1979-11-16
K792173	Models Dm-360 & Dm-350-L Single Patient	Extracorporeal Medical Specialities, Inc.	FKP	Class II	1979-11-16
K792158	3388 Reporting Integrator	Hewlett-Packard Co.	JQP	Class I	1979-11-16
K792111	Conphar Silicone Coated Foley Cath	Conphar, Inc.	KOD	Class II	1979-11-16
K792109	Conphar Latex Foley Cath-Sterile	Conphar, Inc.	KOD	Class II	1979-11-16
K792107	Conphar 100% Silicone Foley Cath-Ster.	Conphar, Inc.	KOD	Class II	1979-11-16
K792103	Hypo-Allergenic Paper Adhesive Tape	National Patent Development Corp.	KGX	Class I	1979-11-16
K792102	Hypo-Allergenic Cloth Adhesive Tape	National Patent Development Corp.	KGX	Class I	1979-11-16
K792096	2 Fr Kelman Chamber Maintainer	Heyer Schulte Corp.	FMI	Class II	1979-11-16