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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3177 of 3528

510(k) clearances, page 3177 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K830152	Miniloop i.v. Connectors & Adaptor	Medex, Inc.	FPA	Class II	1983-02-09
K830148	Cortisol Kit	Cambridge Medical Technology	CGR	Class II	1983-02-09
K830133	Q-Check Culti-Loops	Lab Ability, Inc.	JTR	Class I	1983-02-09
K830124	Option A02 Model 15202A	Hewlett-Packard Co.	CCL	Class II	1983-02-09
K830086	4.5 F Lithotriptor Electrode	Monaghan Medical Corp.	FFK	Class II	1983-02-09
K830081	Bile Esculin Agar	bioMerieux, Inc.	JSJ	Class I	1983-02-09
K830079	Bismuth Sulfite Agar	bioMerieux, Inc.	JSI	Class I	1983-02-09
K830078	Blood Agar(tsa W/5% Sheep Blood)	bioMerieux, Inc.	KZI	Class I	1983-02-09
K830077	Brain Heart Infusion Agar	bioMerieux, Inc.	JSG	Class I	1983-02-09
K830076	Campylocacter Selective Agar Blaser's	bioMerieux, Inc.	JSJ	Class I	1983-02-09
K830075	Columbia Sheep Blood Agar 5%	bioMerieux, Inc.	JSG	Class I	1983-02-09
K830074	Chocolate Agar, Enriched	bioMerieux, Inc.	KZI	Class I	1983-02-09
K830073	Levine Emb Agar	bioMerieux, Inc.	JSH	Class I	1983-02-09
K830072	Hektoen Enteric Agar	bioMerieux, Inc.	JSI	Class I	1983-02-09
K830071	Macconkey Agar	bioMerieux, Inc.	JSI	Class I	1983-02-09
K830070	Mannitol Salt Agar	bioMerieux, Inc.	JSI	Class I	1983-02-09
K830069	Mycobiotic Agar	bioMerieux, Inc.	JSJ	Class I	1983-02-09
K830068	Nutrient Agar	bioMerieux, Inc.	JSG	Class I	1983-02-09
K830067	Phenylethanol Agar W/50% Sheep Blood	bioMerieux, Inc.	JSJ	Class I	1983-02-09
K830066	Sabourand Dextrose Agar	bioMerieux, Inc.	JSJ	Class I	1983-02-09
K830064	Xld Agar	bioMerieux, Inc.	JSI	Class I	1983-02-09
K830063	Contact Plate Lecithin & Polysorbate 80	bioMerieux, Inc.	JSG	Class I	1983-02-09
K830062	Martin-Lewis Agar	bioMerieux, Inc.	JTY	Class II	1983-02-09
K830061	Thayer-Martin, Modified	bioMerieux, Inc.	JTY	Class II	1983-02-09
K830060	Mueller Hinton	bioMerieux, Inc.	JTZ	Class II	1983-02-09
K830059	Mueller Hinton W/50% Sheep Blood	bioMerieux, Inc.	JTC	Class I	1983-02-09
K830034	Model Em-2 Bioelectric Processor	Myo-Tronics Research, Inc.	KZM	Class II	1983-02-09
K823386	Apsara Clinical Diag. & Info. Sys	Datachem, Inc.	JJE	Class I	1983-02-09
K813265	3M Steri-Strip Antimicrobial Skin Clos	3M Company	KGX	Class I	1983-02-09
K830224	Unscented Panty Shields	Weyerhaeuser Co.	HHD	Class I	1983-02-08
K830198	Pediatric Exten. Set for Second-Drug	Travenol Laboratories, S.A.	FMG	Class II	1983-02-07
K830178	Miniloop Dispos. IV Connectors Adapt.	Medex, Inc.	FPA	Class II	1983-02-07
K830177	Harvard Apparatus Family of Fluid Infus	C.R. Bard Inc	FRN	Class II	1983-02-07
K830170	Riassist Rast Data Reduction/quality	Ventrex Laboratories, Inc.	DHB	Class II	1983-02-07
K830169	Dorc Adjustable Image Contacts	JEDMED Instrument Company	HKS	Class I	1983-02-07
K830158	Orexas Potentest	Orexas Medical Corp.	LIL	Unclassified	1983-02-07
K830147	Sigma 300 Gas Chromatrograph	Revvity Health Sciences, Inc.	KZQ	Class I	1983-02-07
K830138	Tandem E Gcg Visual End Point Innumoenz	Hybritech, Inc.	JHI	Class II	1983-02-07
K830137	Calibrator a	Hi Chem, Inc.	JIS	Class II	1983-02-07
K830136	Paramount Thyroxine Assay	Syva Co.	KLI	Class II	1983-02-07
K830122	Continuous Anatomical Passive Exerciser	Zimmer GmbH	BXB	Class I	1983-02-07
K830090	Disposable Bite Block/tongue Depressor	Hudson Oxygen Therapy Sales Co.	JXL	Class II	1983-02-07
K830083	Shur Gel	Columbus Dental Mfg. Co.	ELW	Class II	1983-02-07
K830046	Model Hi-Flo2 Oxygen Rich Air Supply	Greene & Kellogg, Inc.	CAW	Class II	1983-02-07
K830040	Disposable Cystotome	Contemporary Surgical Systems, Inc.	HNY	Class I	1983-02-07
K830020	Acetamide Agar	Gibco Laboratories Life Technologies, Inc.	JSH	Class I	1983-02-07
K823935	Micro Join, Crown & Bridge Adhesive	Sci-Pharm, Inc.	EMA	Class II	1983-02-07
K823900	Glucose-6-Phosphate Dehydrogenase	Alladin Diagnostic, Inc.	KQE	Class II	1983-02-07
K823861	Et-3 Emergency Transport Ventilator	Bio-Med Devices, Inc.	CBK	Class II	1983-02-07
K823718	Sceptor Gram-Positive Panel, Mic/10 Temp	BD Becton Dickinson Vacutainer Systems Preanalytic	JTO	Class I	1983-02-07