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 3390 of 3526

510(k) clearances, page 3390 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791671	Dnase Test Agar	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-10-01
K791670	Sabouraud Agar Modified	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-10-01
K791668	Endoscopic Cytology Brushes	Mill-Rose Laboratory	FDX	Class II	1979-10-01
K791663	Immuchem Covalent Coat Solid Phase Assay	Immuchem Corp.	CDP	Class II	1979-10-01
K791646	Plastic Shower Guard	B & F Medical Products, Inc.	KIA	Class I	1979-10-01
K790775	Intra-Aortic Balloon, Type S	Datascope Corp.	DSP	Class II	1979-10-01
K791978	Sugita Aneurysm Clips, Appliers & Case	Cerenovus, Inc.			1979-09-28
K791784	Cordis Bipolar Pacer Connector System	Cordis US Corp.	DXY	Class III	1979-09-28
K791601	Model 336A Hearing Aids	Telex Communications, Inc.	ESD	Class I	1979-09-28
K791600	Model 33A Hearing Aids	Telex Communications, Inc.	ESD	Class I	1979-09-28
K791599	Model 33Da Hearing Aids	Telex Communications, Inc.	ESD	Class I	1979-09-28
K791548	Rexton Hs(hearing System)	Argosy Intl. (USA), Inc.	HSD	Class II	1979-09-28
K791467	Ta-10 Portable Screening Audiometer	Teledyne Avionics Div. of Teledyne	EWO	Class II	1979-09-28
K791310	Dahlberg Hearing Aid Model Gc	Dahlberg Electronics, Inc.	ESD	Class I	1979-09-28
K791204	Miter Endosteal Blade Implant	Depuy, Inc.	NRQ	Class II	1979-09-28
K791142	Hearing Aid, Model Ma-1	Starkey Laboratories, Inc.	KLW	Class II	1979-09-28
K790068	Pulse Generators, Models 5983, 5989	Medtronic, Inc.	DXY	Class III	1979-09-28
K791835	Coralent Coat 125I Cortisol Radioimm.	Radioassay Systems Laboratories, Inc.	CGR	Class II	1979-09-27
K791828	Bjork-Shiley Pulmonic Graft Valve	Shiley, Inc.	DSY	Class II	1979-09-27
K791795	Comp-Act IV	Medcraft Corp.	DPS	Class II	1979-09-27
K791760	Glucose Hexokinase Coil Reagent System	Fisher Scientific Company L.L.C.	CFR	Class II	1979-09-27
K791754	Uric Acid Reagent	Gilford Diagnostics	KNK	Class I	1979-09-27
K791740	Serum 11-Desoxycortisol I as Tracer	Radioassay Systems Laboratories, Inc.	JKB	Class I	1979-09-27
K791728	Rsl's Assay Procedure Quantitation	Radioassay Systems Laboratories, Inc.	CGI	Class I	1979-09-27
K791727	Implantable Ventricular-Inhibited	Telectronics, Inc.	DXY	Class III	1979-09-27
K791715	Arcolith 2000	Arco Medical Products Co.	DXY	Class III	1979-09-27
K791664	Immuchem Covalent Coat Solid Phase Assay	Immuchem Corp.	CDX	Class II	1979-09-27
K791662	Immuchem Covalent Coat Binding	Immuchem Corp.	KHQ	Class II	1979-09-27
K791652	Estradiol Kit by Ria	Radioassay Systems Laboratories, Inc.	CHP	Class I	1979-09-27
K791651	Total Estrogens Kit by Ria	Radioassay Systems Laboratories, Inc.	JMD	Class I	1979-09-27
K791631	Sabouraud Dextrose Agar	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-09-27
K791630	Brain Heart Infusion Agar	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-09-27
K791629	Brain Heart Cc Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-09-27
K791628	Brain Heart Infusion Agar 5% Sheep Blood	Isle Media and Sterile Products, Inc.	JSG	Class I	1979-09-27
K791627	Mannitol Salt Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1979-09-27
K791626	Mycobiotic Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-09-27
K791623	Tryptic Soy Broth	American Laboratory Supply, Inc.	JSC	Class I	1979-09-27
K791588	Ventre/sep T3 Test Set	Ventrex Laboratories, Inc.	CDP	Class II	1979-09-27
K791578	Campylobacter Selective Medium	Anaerobe Systems	JSJ	Class I	1979-09-27
K791549	Technicon Star System	Technicon Instruments Corp.	DON	Class II	1979-09-27
K791365	Fast Flow #60310	Hi Chem, Inc.	LCP	Class II	1979-09-27
K791298	Diagnostic Ultrasound System	Xonics Medical Systems, Inc.	IYO	Class II	1979-09-27
K791128	Pth Ria 200	Institut National des Radioelements	CEW	Class II	1979-09-27
K790347	Auto Pak Vitamin B-12	Micromedic Systems	CDD	Class II	1979-09-27
K781445	Spreader	Orthopedic Equipment Co., Inc.	GAD	Class I	1979-09-27
K791856	Y & Elbow W/wo Ports	Airlife, Inc.	BZO	Class I	1979-09-26
K791821	Corrugated Flexible Polyethylene & Eva	Airlife, Inc.	BYX	Class I	1979-09-26
K791820	I.p.p.b. Manifolds & Neb. Sing. & Dbl	Airlife, Inc.	CAF	Class II	1979-09-26
K791819	Air Incentive Spirometer	Airlife, Inc.	BWF	Class II	1979-09-26
K791751	Edwards Pacemaker 30 Unipolar Generator	Edwards Pacemaker Systems	DXY	Class III	1979-09-26