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 3414 of 3526

510(k) clearances, page 3414 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790358	Fluid Administration Cat.#14-923	Norton Performance Plastics Corp.	GAZ	Class II	1979-03-21
K790346	Activator	Tri-Med, Inc.	JBP	Class II	1979-03-21
K790345	Stimtech TENS Electrode	Stimulation Technology, Inc.	GXY	Class II	1979-03-21
K790323	Coag-a-Mate 2001	General Diagnostics	JPA	Class II	1979-03-21
K790319	Ortho-Toluidine Reagent Set	Fisher Scientific Company L.L.C.	CGE	Class II	1979-03-21
K790311	Ldh Isoenzyme Reagent	Electrophoresis Corp.	CFE	Class II	1979-03-21
K790310	Hemoglobin Controls	Electrophoresis Corp.	GGM	Class II	1979-03-21
K790302	Pressure Monitor, Model 212	Zatek	HRW	Class I	1979-03-21
K790294	Buffer, Corning Mopso	Corning Medical & Scientific	JHX	Class II	1979-03-21
K790281	Diagnostic Set, Lipo-Frax	Analytical Products, Inc.	LBS	Class I	1979-03-21
K790273	Mammography System and Cassette	AGFA Healthcare Corp.	IZH	Class II	1979-03-21
K790267	Sensi-Tex	Hoffmann-La Roche, Inc.	JHJ	Class II	1979-03-21
K790264	Data-Tope Tri-Rac Radioassay Control	Dade, Baxter Travenol Diagnostics, Inc.	JJY	Class I	1979-03-21
K790260	Ntsh Autopak Test Delivery System	Micromedic Systems	JLW	Class II	1979-03-21
K790183	Portable Wheelchair & Carrying Case	Fred Sammons, Inc.	IOR	Class I	1979-03-21
K790167	Sunlamp	Kneilsly Group Ent.	FTC	Class II	1979-03-21
K790129	Serum Pak, Hcg Control	Mallinckrodt Critical Care	JJX	Class I	1979-03-21
K790060	Needle II, Burron Filter	National Patent Development Corp.	GAA	Class I	1979-03-21
K782165	Phaseafill	Phasealloy	EBF	Class II	1979-03-21
K782081	Ria System, Parathyroid Hormone	Iso-Tex Diagnostics	CEW	Class II	1979-03-21
K782061	Spinal Surgery Instrumentation	Stuart Drug & Surgical Supply, Inc.	KWQ	Class II	1979-03-21
K782055	Cream, Signa	Parker Laboratories, Inc.	GYB	Class II	1979-03-21
K782051	Drapes, Disposable Surgical	Marco Mfg.	KKX	Class II	1979-03-21
K782021	A.v. Fistula Needle Set	Cordis US Corp.	FIE	Class II	1979-03-21
K781973	Cardiophone	North American Motronic	DXY	Class III	1979-03-21
K790432	Microlith Models 505;605;507;607;703;803	Cardiac Pacemakers, Inc.	DXY	Class III	1979-03-20
K790566	Pacemaker, Ovalith-D Cardiac	Caratomic	DXY	Class III	1979-03-19
K790468	Implantable Heart Lead Extender	Arco Medical Products Co.	DTD	Class II	1979-03-19
K790412	Model 337E Hearing Aid	Telex Communications, Inc.	ESD	Class I	1979-03-19
K790303	Emit Auto Digoxin Assay	Syva Co.	KXT	Class II	1979-03-19
K790214	Modified Jackson-Rees Circuit	Vital Signs, Inc.	CAI	Class I	1979-03-19
K790205	Electroapplicator Model C-1	Mcg, Inc.	KTB	Class II	1979-03-19
K790117	Autosampler, Model as-40	Revvity Health Sciences, Inc.	JXR	Class I	1979-03-19
K790470	The Guardian Sphygmomanometer	World Book Encyclopedia, Inc.	DXN	Class II	1979-03-16
K790413	Heifetz Aneurysm Clip, Lmm Blade	Edward Weck, Inc.	HCH	Class II	1979-03-16
K790277	Quick-Check	United States Surgical, A Division of Tyco Healthc	DXN	Class II	1979-03-16
K790166	Oxygen Mask, Adult Vinyl	Airlife, Inc.	BYG	Class I	1979-03-16
K790115	Breathing Circuit, Disposable	H.B. Laboratories, Inc.	CAI	Class I	1979-03-16
K790109	Telemetry, Biomedical	LKC Technologies, Inc.	DRG	Class II	1979-03-16
K790402	Emit-Quinidine Control	Syva Co.	LAS	Class I	1979-03-15
K790375	Tryptic Soy Agar W/ 5% Horse Blood	Granite Diagnostics, Inc.	JSG	Class I	1979-03-15
K790351	Rheumatell	Central Biological Co.	DHR	Class II	1979-03-15
K790330	Calbiochem-Behring Laser Immunoglobulin	Calbiochem-Behring Corp.	JJY	Class I	1979-03-15
K790257	Systemic Lupus	Icl Scientific	DHC	Class II	1979-03-15
K790252	Anti-Native Deoxyrib-Onucleic Acid Anti	Meloy Laboratories, Inc.	DHN	Class II	1979-03-15
K790236	Spectrophotometer Model 650-40	Revvity Health Sciences, Inc.	KHO	Class I	1979-03-15
K790235	Spectrophotometer Model 3000	Revvity Health Sciences, Inc.	KHO	Class I	1979-03-15
K790211	Dehydrogenose, Glucose Phosphate	Sigma Chemical Co.	JBL	Class II	1979-03-15
K790106	Iif-a-N-DNA Test Kit	Medica Corp.	DHC	Class II	1979-03-15
K790059	Proactivator C3, C4 and C3	Icl Scientific	KTP	Class II	1979-03-15