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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2866 of 3529

510(k) clearances, page 2866 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862234	Exactech Total Hip System	Exactech, Inc.	JDI	Class II	1986-10-15
K862092	Comfortron	M. D. Supply, Inc.	KZM	Class II	1986-10-15
K863890	Mamm-Aire	Ar Custom Medical Products, Ltd.	KXH	Class I	1986-10-14
K863856	S-Ray Camera	Uni-Quatro Industries	LMC	Class II	1986-10-14
K863850	Dressing, First Aid, Field, Various Sizes	Fraass Survival Systems, Inc.	EFQ	Unclassified	1986-10-14
K863848	Manan Brest Tumor Localization Needle	Manan Manufacturing Co., Inc.	GAA	Class I	1986-10-14
K863836	Post Tray	Market Masters, Inc.	EHY	Class I	1986-10-14
K863831	Vivadent Filpin	Vivadent (USA), Inc.	EBL	Class I	1986-10-14
K863814	Bag Spike Extension Set	Med Fusion Systems, Inc.	FPA	Class II	1986-10-14
K863808	The S. Cordero Stylus	S. Cordero Co.	GDZ	Class I	1986-10-14
K863800	Endoscopic Video Camera	Technology for Imaging, Inc.	KQM	Class I	1986-10-14
K863799	Jaw Fixation Assembly	Medical Products & Research, Inc.	DYX	Class II	1986-10-14
K863788	Sawblade	Tava Surgical Instruments	GFA	Class I	1986-10-14
K863787	Pa Equalizer	Electone, Inc.	ESD	Class I	1986-10-14
K863737	Sponges Sterile Twin Pakt and Singles	Hermitage Hospital Products, Inc.	EFQ	Unclassified	1986-10-14
K863733	Towel Pack, Surgical	East Texas Lighthouse for the Blind			1986-10-14
K863726	Instrument Sterilization Tray	Medical Technology Development Corp.	FSM	Class I	1986-10-14
K863721	Norfolk Medical Posi-Grip 'Huber Point' Needle	Norfolk Medical Products, Inc.			1986-10-14
K863714	Bandage, Gauze, Six-Ply, Various Sizes	Fraass Survival Systems, Inc.	EFQ	Unclassified	1986-10-14
K863713	Bandage, Gauze, Two-Ply, Various Sizes	Fraass Survival Systems, Inc.	EFQ	Unclassified	1986-10-14
K863710	Alpha S/d Diagnostic X-Ray Mammography Unit	Ausonics Pty, Ltd.	IZH	Class II	1986-10-14
K863701	Model 709 Bipolar Micro Coagulator	Bergen Mfg.	GEI	Class II	1986-10-14
K863690	Stand, Irrigator, Steel, Folding	Brenner Metal Prod Corp.			1986-10-14
K863482	Drainovac Complete Closed Wound Drainage Device	Cardio Metrics, Inc.	GCY	Class I	1986-10-14
K863479	Modified Ict/b Intracranial Press. Trans. Epidural	Medical Measurements, Inc.	GWM	Class II	1986-10-14
K863121	Peak Ovulation Predictor	Micron Technology, Inc.	NGE	Class I	1986-10-14
K863089	Disposable Laser Sponge Surgimedics, 902001-000	Lifestream Int'L, Inc.	GDY	Class I	1986-10-14
K862546	Microfill Pontic	Kulzer GmbH	EBF	Class II	1986-10-14
K862233	Ciba Corning Prisma T4 Lipia (Liposome)	Ciba Corning Diagnostics Corp.	KLI	Class II	1986-10-14
K861884	Neuroscope Seeg	Siegen Corp.	GWO	Class II	1986-10-14
K863729	Ophthalmic Fitler Micro Capsule	Ipax, Inc.	HQC	Class II	1986-10-10
K863682	Pathfinder(tm) Specimen Collection Kit	Kallestad Laboratories, Inc.	JSM	Class I	1986-10-10
K863651	Polarex and Polarex Mld	Selex, Inc.	HQY	Class I	1986-10-10
K863591	Endophotocoagulation Probe	Mira, Inc.	HQF	Class II	1986-10-10
K863564	Uresil Irrigation Catheter	Uresil, LLC	DQY	Class II	1986-10-10
K863559	Uresil Occlusion Balloon Catheter	Uresil, LLC	DQT	Class II	1986-10-10
K863305	Hickman Subcutaneous Port W/pre-Attached Catheter	C.R. Bard Inc	LJT	Class II	1986-10-10
K863139	Terumo Radifocus Introducer Kit	Terumo Medical Corp.	DYB	Class II	1986-10-10
K863137	Terumo Radifocus Angiographic Catheter	Terumo Medical Corp.	DQO	Class II	1986-10-10
K863011	Dentatus Ls/euroflex F-Iv/isolight Reflect/cm-II	Sds Dental, Inc.			1986-10-10
K854236	Histamine Ria Test for Histamine Biological Fluids	Nms Pharmaceuticals, Inc.	IAF	Class I	1986-10-10
K863821	Mueller Hinton Agar W/4%nacl and Oxacillin	Gibco Laboratories Life Technologies, Inc.	JTZ	Class II	1986-10-09
K863811	Amebiasis Microassay	Diamedix Corp.	KHW	Class II	1986-10-09
K863748	Hospital Bed	Global Medical Prods, Inc.	FNJ	Class I	1986-10-09
K862773	Phonic Ear, Model Pe475r	Phonic Ear, Inc.	EPF	Class II	1986-10-09
K850425	Dental Anesthesia Apparatus	Pain Prevention, Inc.	KZM	Class II	1986-10-09
K863820	Dri-Form: Gbna Listeria Medium No. M22300	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1986-10-08
K863640	Modified Gas Sampling Kit	Respiratory Support Products, Inc.	CCK	Class II	1986-10-08
K863582	Model 725Th Handheld Transceiver (Programmer)	Cook Pacemaker Corp.	DXY	Class III	1986-10-08
K863417	Cordis Multicor II Model 402D Pacer	Cordis US Corp.	DXY	Class III	1986-10-08