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 1734 of 3531

510(k) clearances, page 1734 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991607	Vantage 2.5	Philips North America LLC	KPS	Class II	1999-07-26
K991322	Enhance-S Plus	Conception Technology, Inc.	MQL	Class II	1999-07-26
K991110	Redi-Test Cocaine	Redwood Biotech, Inc.	DIO	Class II	1999-07-26
K991065	Careside Pt	Careside, Inc.	GJS	Class II	1999-07-26
K990350	Wallace Catheters-18Cm, Model 1816; 23Cm, Model 1816N; 23Cm, Model 2316	CooperSurgical, Inc.	MQF	Class II	1999-07-26
K990349	Wallace Malleable Stylet-18Cm, Model 1816St, Wallace Malleable Stylet-23Cm, Model 1816Nst	CooperSurgical, Inc.	MQF	Class II	1999-07-26
K990348	Wallace Trial Transfer Catheter, Model Tt 1816N	CooperSurgical, Inc.	MQF	Class II	1999-07-26
K984428	Sullivan Autoset Nasal CPAP System	ResMed Corp	BZD	Class II	1999-07-26
K984060	Luer Access Injection Site	Baxter Healthcare Corporation	FPA	Class II	1999-07-26
K992231	FOUNTAIN Infusion Catheter and Occluding Guide Wire	Merit Medical Systems, Inc.	QEY	Class II	1999-07-23
K992205	Pre-Powdered Vinyl Patient Examination Gloves	Shanghai China Star Corp	LYZ	Class I	1999-07-23
K992041	Relisa Ana Screening Test System, Model 7096-11	IMMUNO CONCEPTS, NA, Ltd.	LJM	Class II	1999-07-23
K992034	Document Thyroid Cal*ver	Casco-Nerl Diagnostics Corporation (Maine)	JJY	Class I	1999-07-23
K992021	Brightway Brand Latex Surgical Gloves - Sterile (Powder Free)	Brightsway Holdings Sdn Bhd	KGO	Class I	1999-07-23
K991586	Sscs (Segmental Spinal Correction System)	Osteotech Inc	KWP	Class II	1999-07-23
K991446	Biosaca System, Model 800	Biosys AB (Publ)	OLV	Class II	1999-07-23
K990823	Pvs 1400 Guidewire	Precision Vascular Systems, Inc.	DQX	Class II	1999-07-23
K990732	Lap-Wave 3000 (P07)	Novanta Medical GmbH	HET	Class II	1999-07-23
K990618	Ventana Pgr Primary Antibody (Clone 1A6)	Ventana Medical Systems Inc	MXZ	Class II	1999-07-23
K990579	Cryocheck La Check, Models Chk25-10 (25 X1.0 Ml), Chk80-10 (80 X 1.0 Ml)	Precision BioLogic Inc.	GIR	Class I	1999-07-23
K980070	Osteonics Ha-Coated Devices	Osteonics Corp.	MEH	Class II	1999-07-23
K992207	Quikstrip One Step Cocaine Assay (Cocaine and Cocaine Metabolite Test System	Syntron Bioresearch, Inc.	DIO	Class II	1999-07-22
K991817	Additional Ims Assays for the Bayer Advia Ims System	Bayer Corp.	CIJ	Class II	1999-07-22
K991741	Biocheck Hcg Enzyme Immunoassay Test Kit, Model Bc-1027	BioCheck Inc	JHI	Class II	1999-07-22
K991723	Transfx Multi Pin Clamp	Immedica, Inc.	LXT	Class II	1999-07-22
K991598	Cobas Integra Acetaminophen	Roche Diagnostics GmbH	LDP	Class II	1999-07-22
K991597	Cobas Integra Amikacin Mab	Roche Diagnostics GmbH	LGJ	Class II	1999-07-22
K991504	Redi-Test Methamphetamine	Redwood Biotech, Inc.	LAF	Class II	1999-07-22
K991449	Snore-Aid Plus	Dental Imagineers, LLC	LRK	Class II	1999-07-22
K991424	Insulscan Insulation Testing System	Medicor Corp.	HFG	Class II	1999-07-22
K990476	Hp Viridia Component Monitoring System, Hp Viridia Cms 24/26, Model Rev. K with Easi-ECG Option	Hewlett-Packard Co.	MHX	Class II	1999-07-22
K992328	Fuzzy Automatic Blood Pressure Monitor Models Md-750, Md-770, Md-800	Meditec Co., Ltd.	DXN	Class II	1999-07-21
K992142	Scimed Angiographic Catheters	Scimed	DQO	Class II	1999-07-21
K991844	Pro-Glass	Cad Cam Ventures	EIH	Class II	1999-07-21
K991588	Ems Swiss Orthoclast	(Ems Sa) Electro Medical Systems	HSZ	Class I	1999-07-21
K991557	Medrad Vistron CT Injector System	Medrad, Inc.	DXT	Class II	1999-07-21
K984392	Ansell Condoms	Ansell, Inc.	HIS	Class II	1999-07-21
K992000	Synthes Cranial Flap Tube Clamp	Synthes (USA) Products LLC	GXN	Class II	1999-07-20
K991957	Cicacare Management for Scars	Smith & Nephew, Inc.	MDA	Class I	1999-07-20
K991865	Q-Lite 75 Light Cure Unit	Rolence Enterprise Co., Ltd.	EBZ	Class II	1999-07-20
K991860	Synthes Cranial Flap Twist Clamp	Synthes (USA) Products LLC	GXN	Class II	1999-07-20
K991636	Elekta Stereotactic Guide	Elekta Instrument AB	HAW	Class II	1999-07-20
K991609	Dermaphylyx Super Absorbent Fiber Dressing	Dermaphylyx, Inc.	KMF	Class I	1999-07-20
K991608	Dermaphylyx Calcium Alginate Wound Dressing	Dermaphylyx, Inc.	KMF	Class I	1999-07-20
K991525	Deroyal Sterile Neonatal Blood Pressure Cuff	DeRoyal Industries, Inc.	DXQ	Class II	1999-07-20
K991469	Aware Pad	Aac Consulting Group, Inc.	IYO	Class II	1999-07-20
K991464	Dental 200, Dental 300, Dental 400, Models E-20, E-60, E-50	Fisma, Inc.	GEX	Class II	1999-07-20
K991416	Endoscopic Camera	Genzyme Surgical Product (Genzyme Biosurgery)	GCJ	Class II	1999-07-20
K990712	Osteonics Solar Shoulder Bipolar System	Howmedica Osteonics Corp	MJT	Class III	1999-07-20
K990656	Chromophare D 530 Ldr Surgical Light	Berchtold Holding GmbH	FSY	Class II	1999-07-20