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 3475 of 3526

510(k) clearances, page 3475 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771684	Amplifier Model N5a-ECG	Honeywell, Inc.	DRJ	Class I	1977-09-14
K771681	Ortho H Film	Eastman Kodak Company	IWZ	Class I	1977-09-14
K771668	Disp. Fluid Isolator & Press. Relief	Ailtech	DRS	Class II	1977-09-14
K771642	Adapter a-413	Pacesetter Systems	DTD	Class II	1977-09-14
K771641	Universal Lead Adapter, Ua-414	Pacesetter Systems	DTD	Class II	1977-09-14
K771567	Endocard. Pacing Lead-Long Length Pl203	Daig Corp.	DTB	Class III	1977-09-14
K771566	Endocar. Pacing Lead-Std. Length Pl202	Daig Corp.	DTB	Class III	1977-09-14
K771565	Endocard. Pacin/ Lead-Long Length Pl200	Daig Corp.	DTB	Class III	1977-09-14
K771564	Endocard. Pacin/ Lead-Std. Length Pl100	Daig Corp.	DTB	Class III	1977-09-14
K771369	Liq. Scintillation Spectrophotometeo	Beckman Instruments, Inc.	JJJ	Class I	1977-09-14
K771306	Thermocath	Victory Engineering Corp.	DYG	Class II	1977-09-14
K771699	Cara-Stain Model 3000	American Safety Equipment Corp.	KPA	Class I	1977-09-13
K771622	Multistat III, Amylase Test	Instrumentation Laboratory Co.	JFJ	Class II	1977-09-13
K771621	Multistat III, Total Bilirubin Test	Instrumentation Laboratory Co.	CIG	Class II	1977-09-13
K771597	In Vitro Folate Radioassay Kit	Clinical Assays, Inc.	CGN	Class II	1977-09-13
K771585	T3 Uptake Diag. Kit	Antibodies, Inc.			1977-09-13
K771584	Arteoial Blood Sampling Kit 2D9014	Travenol Laboratories, S.A.	FMF	Class II	1977-09-13
K771582	Holesterol Delta Test Assay	BD Becton Dickinson Vacutainer Systems Preanalytic	CHH	Class I	1977-09-13
K771509	Multistat III Uric Acid Test	Instrumentation Laboratory Co.	CDO	Class I	1977-09-13
K771508	Multistat III Cholesterol Test	Instrumentation Laboratory Co.	CHH	Class I	1977-09-13
K771475	Multistat III Albumin Test	Instrumentation Laboratory Co.	CIX	Class II	1977-09-13
K771474	Multistat III X-Hbdh Test	Instrumentation Laboratory Co.	JMK	Class I	1977-09-13
K771473	Multistat III Y Gt Test	Instrumentation Laboratory Co.			1977-09-13
K771671	Auditory Trainer	Accutone, Inc.	EPF	Class II	1977-09-12
K771670	Implanted Pacemaker Pluse Generator	Telectronics, Inc.	DXY	Class III	1977-09-12
K771665	Oxygen Concentrator	Mtc	CAW	Class II	1977-09-12
K771664	Volumetric Infusion Pump Model 960	Imed Corp.	FRN	Class II	1977-09-12
K771661	Middlebrook 7H11 Agar (Plate)	Granite Diagnostics, Inc.	JSJ	Class I	1977-09-12
K771658	Identoflex	Cavitron Corp.	EHJ	Class I	1977-09-12
K771653	Electronic Stethoscope	3M Company	DQD	Class II	1977-09-12
K771633	Heel Protector	Medical Restraints, Inc.	FMP	Class I	1977-09-12
K771631	Wheelchair Safety Belt	Medical Restraints, Inc.	KNN	Class I	1977-09-12
K771626	Pacemaker Model 251	Intermedics, Inc.	DXY	Class III	1977-09-12
K771625	Leiningeo Aortic Punch #310-395 & 397	J. Jamner Surgical Instruments, Inc.	DWS	Class I	1977-09-12
K771618	Computerized Posture Platform	Contraves Goerz Corp.	LXV	Unclassified	1977-09-12
K771593	i.v. Pump Set for Fat Emulsion	Abbott Medical	FPA	Class II	1977-09-12
K771563	Conform Elastic Netting	Kendall Research Center	FQM	Class I	1977-09-12
K771514	Pregnancy Test Kit	Generic Laboratory, Ltd.	JHJ	Class II	1977-09-12
K771477	Multistat III Phosphorous Test	Instrumentation Laboratory Co.	CEO	Class I	1977-09-12
K771476	Multistat III Total Protein Test	Instrumentation Laboratory Co.	CEK	Class II	1977-09-12
K771471	Multistat III Glucose Test	Instrumentation Laboratory Co.	CGA	Class II	1977-09-12
K771470	Multistat III Alkaline Phosphatase	Instrumentation Laboratory Co.	CJE	Class II	1977-09-12
K771469	Multistat III Magnesium Test	Instrumentation Laboratory Co.	JGJ	Class I	1977-09-12
K771468	Multistat III Calcium Test	Instrumentation Laboratory Co.	CIA	Class II	1977-09-12
K771452	Conform Stretch Bandage (5Sizes)	Kendall Research Center	ITG	Class I	1977-09-12
K771416	Irrigation/aspiration Needle	Concept, Inc.	HMX	Class I	1977-09-12
K771272	Disp. Syringes: 2,5 & L0 Mi.	Berman, Pcp & Consultants, Inc.	FMF	Class II	1977-09-12
K771271	Scalp Vein Set	Berman, Pcp & Consultants, Inc.	FPA	Class II	1977-09-12
K771270	Blood Administration Type R	Berman, Pcp & Consultants, Inc.	FPA	Class II	1977-09-12
K771269	Blood Collection Set Type H	Berman, Pcp & Consultants, Inc.	FPK	Class II	1977-09-12