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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2252 of 3531

510(k) clearances, page 2252 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925319	A-Dec 2182 Doctor's Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925318	A-Dec 2181 Duo Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925317	A-Dec 2180 Duo Unit, Cusp	A-dec, Inc.	KLC	Class I	1993-12-09
K925316	A-Dec 2172 Doctor's Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925315	A-Dec 2171 Duo Unit	A-dec, Inc.	KLC	Class I	1993-12-09
K925314	A-Dec 2170 Duo Unit Cusp	A-dec, Inc.	KLC	Class I	1993-12-09
K923759	Fluorescent T12 Uva Tanning Lamp	Quality Lamp, Inc.	LEJ	Class II	1993-12-09
K934858	Frame Spectacle	Arno Intl., Inc.	HQZ	Class I	1993-12-08
K934852	Cool Kids Hip Shades	Ja-Ru, Inc.	HQY	Class I	1993-12-08
K934837	Sunglasses	Simon Marketing, Inc.	HQY	Class I	1993-12-08
K934797	Fine Optics	Fine Optics, Inc.	HQZ	Class I	1993-12-08
K934726	Fep Ringed Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DYF	Class II	1993-12-08
K934463	Spectacle Frame	Good Bond Industrial Corp.	HQZ	Class I	1993-12-08
K934403	Sunglasses	Sun Share Merchandise Corp.	HQY	Class I	1993-12-08
K934374	Sunglasses (Non-Prescription)	Immmex Company, Ltd.	HQY	Class I	1993-12-08
K934301	Spectacle Frames	Gernot Lindner, Lunor-Vertrieb	HQZ	Class I	1993-12-08
K934248	Alpha-Dent Tissue Conditioner and Temporary Reliner	Wallace A. Erickson & Co.	EBI	Class II	1993-12-08
K933943	Fep Ringed Gore-Tex Stretch Vascualr Graft with Removable Rings	W. L. Gore & Associates, Inc.	DSY	Class II	1993-12-08
K933814	Photostress Recovery Tester	Storz Instrument Co.	GXY	Class II	1993-12-08
K933393	Elias Cardiolipin Igg Antibodies	Elias U.S.A., Inc.	MID	Class II	1993-12-08
K933392	Elias Cardiolipin Igm Antibodies	Elias U.S.A., Inc.	MID	Class II	1993-12-08
K932757	Securodrip (Tm) i.v. Armboard	Op-Co Medical Products, Ltd.	KMK	Class I	1993-12-08
K932537	Scimed Maverick Pta Catheter	Scimed Life Systems, Inc.	LIT	Class II	1993-12-08
K932172	Medtronic Models 4057M,4058m,4557m, Pacing Leads	Medtronic, Inc.	DTB	Class III	1993-12-08
K930893	Mitek Super Quickanchor, Modification	Mitek Surgical Products, Inc.	JDR	Class II	1993-12-08
K930331	Spectacle Frame	Australian Optical Co., Inc.	HQZ	Class I	1993-12-08
K925539	Sunglasses	Sunshine Opticians, Inc.	HQY	Class I	1993-12-08
K934900	Glucometer Encore Qa Blood Glucose Meter Modification	Kulzer GmbH	CFR	Class II	1993-12-07
K934898	Glucometer Qa Blood Glucose Meter Modification	Kulzer GmbH	CGA	Class II	1993-12-07
K934801	Spinpro Hdl Precipitating Reagent	Merchant House Scientific	LBR	Class I	1993-12-07
K934534	Trocar W/cannula, O Ring, Adapter, and Adapter Sleeve Modification	Baxter Healthcare Corporation	GCJ	Class II	1993-12-07
K934376	Stc Diagnostics Auto-Lyte Barbiturates Eia	Solarcare, Inc.	DIS	Class II	1993-12-07
K934267	Damor Cream Saturated Dressing	Damor America, Inc.	MGQ	Unclassified	1993-12-07
K933977	Aircast Edemaflow System	Aircast, Inc.	JOW	Class II	1993-12-07
K933929	Lab-Site(r) Safety Cannula	Simplivia Healthcare Ltd.	CBF	Class II	1993-12-07
K933328	Damor Creme	Damor America, Inc.	MGQ	Unclassified	1993-12-07
K932304	Micro Eia for Amphetamine Metabolites	Microdiagnostics, Inc.	DKZ	Class II	1993-12-07
K932068	Peritemp Pf 4005 Heater	Perimed AB	DPW	Class II	1993-12-07
K931196	Apec Glucose Analyzer	Apec, Inc.	CGA	Class II	1993-12-07
K923729	Ureteral Catheter	Cook Incorporated	EYB	Class II	1993-12-07
K934584	Spectrolyse Factor Vii:c	Meditech	GGP	Class II	1993-12-06
K934497	Cbc-Stk(tm) Hematology Control/multiple	R & D Systems, Inc.	JCN	Class II	1993-12-06
K934351	Aptt-Es Reagent	Medical Diagnostic Technologies, Inc.	GFO	Class II	1993-12-06
K934064	Reflotron Hemoglobin Test Tabs	Boehringer Mannheim Corp.	KHG	Class II	1993-12-06
K933831	Permasoft Soft Reline Material by Nu-Dent, Inc.	Nu-Dent, Inc.	EBI	Class II	1993-12-06
K931824	Carapace Instrumlent and Instrument Sets	Carapace, Inc.	LRO	Class II	1993-12-06
K931629	Carapace Angiography Trays	Carapace, Inc.	DQO	Class II	1993-12-06
K931556	Argenco M	Argen Precious Metals, Inc.	EJT	Class II	1993-12-06
K926549	Endocath Electrophysiology Catheter	Endo-Therapeutics, Inc.	DRF	Class II	1993-12-06
K926381	Ocusystem Iie	Surgeon Design	HQC	Class II	1993-12-06