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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3325 of 3528

510(k) clearances, page 3325 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802229	Chemical Indicator - Kem Med & Bio Sure	Kem Medical Products Corp.	JOJ	Class II	1980-12-09
K802228	Biological Indicator - Kemmed & Biosure	Kem Medical Products Corp.	FRC	Class II	1980-12-09
K803077	Biolumin. Screening for Bact. by Atp a.	Technology, Inc.			1980-12-05
K802556	Phadebas Rast Test	Pharmacia, Inc.	DHB	Class II	1980-12-02
K802551	Generator, High Volt, X-Ray, Mpx100/125	General Electric Co.	IZO	Class I	1980-12-02
K802550	Generator, High Volt, X-Ray, Mpx 125	General Electric Co.	IZO	Class I	1980-12-02
K802549	Generator, High Volt, X-Ray, Mpx 100	General Electric Co.	IZO	Class I	1980-12-02
K802548	Generator, High Volt, X-Ray, Diag. Mpx80	General Electric Co.	IZO	Class I	1980-12-02
K802507	Tensmate Empimodel 9980	Empi	GZJ	Class II	1980-12-01
K802484	Sinvision 2001 Ultrasound Scanner	National Ultrasound Corp.			1980-12-01
K802432	Glyco-Trol Human Glycosylated Hom. Cont.	Clin Tech Diagnostics Corp.	LCP	Class II	1980-12-01
K802356	Von Willebrand Factor Assay	Bio/Data Corp.	GGP	Class II	1980-12-01
K802309	Ms-2 Identification System	Abbott Medical	JXB	Class I	1980-12-01
K802308	T/k (Ata/ama) Universal Biopak	Bioware Products	DBM	Class II	1980-12-01
K802304	Solar Tone	Bloomex International, Inc.	LEJ	Class II	1980-12-01
K802124	Gristina Glenoid Prosthesis	Howmedica Corp.	KWT	Class II	1980-12-01
K802054	Travenol Ultrasonic Nebulizer Cups	Travenol Laboratories, S.A.	CAP	Class II	1980-12-01
K801324	Siemens-Elema Pulse Generator 668	Siemens Elema AB	DXY	Class III	1980-12-01
K801284	Low Profile Lead Connector Modification (4002)	Medtronic, Inc.	DTB	Class III	1980-12-01
K801172	Intermedics' Lifeline Tle Endocardial	Intermedics, Inc.	DTB	Class III	1980-12-01
K802088	Auxiliary Tray	American Pharmaseal Div. Ahsc	FSM	Class I	1980-11-28
K802812	Rionet Hearing Aid	Kindel & Anderson	KHL	Class II	1980-11-26
K802763	Respirgard	Marquest Medical Products, Inc.	CAH	Class II	1980-11-26
K802762	Normocap Cr-102, Recorder Unit	Instrumentarium-Datex	CCL	Class II	1980-11-26
K802718	Model 4700A Electrocardiograph	Hewlett-Packard Co.	DPS	Class II	1980-11-26
K802714	Cobe/stockert Battery Module	Cobe Laboratories, Inc.	DWB	Class II	1980-11-26
K802712	Entermed Entunit	JEDMED Instrument Company	ETF	Class I	1980-11-26
K802686	Hp Model 8880A Filter	Hewlett-Packard Co.	DRR	Class II	1980-11-26
K802670	Contiuous Wave Doppler Ultrasound	American Edwards Laboratories	DXK	Class II	1980-11-26
K802666	Aptek Ultrasound Procedure Tray	Aptek, Ltd.	HIO	Class I	1980-11-26
K802656	Model T-6 EEG Telephone Transmitter	Telediagnostic Systems, Inc.	GYE	Class II	1980-11-26
K802648	Uca Cream Product Reformulation	Vanaray Laboratories, Inc.	GYB	Class II	1980-11-26
K802637	Teca Model-10 Electromyograph	Teca, Inc.	IKN	Class II	1980-11-26
K802630	Caffeine Reagent Diazo Colorimetry	American Monitor Corp.	CIG	Class II	1980-11-26
K802609	Chemistry Analyzer Impact 400	Gilford Instrument Laboratories, Inc.	JJE	Class I	1980-11-26
K802475	A2 Image Processing System	Medtronic, Inc.	IYX	Class I	1980-11-26
K802472	Biometric Erg System	Biometric Analysis Group, Inc.	DSI	Class II	1980-11-26
K802396	General Procedure Agarose Film	Electrophoresis Corp. of America	JJN	Class I	1980-11-26
K802395	Special Procedure Aqarose Film	Electrophoresis Corp.	JJN	Class I	1980-11-26
K802316	Pds Thermal Dilution Cardiac Module(out)	General Electric Co.	DXG	Class II	1980-11-26
K802289	Pericardiocentesis Kit	Stanco Medical, Inc.	DOR	Class II	1980-11-26
K802254	General Ultrasound Exam. Table	Engineering Dynamics Corp.	IYN	Class II	1980-11-26
K802874	Arteriovenous Blood Tubing Sets	Extracorporeal Medical Specialities, Inc.	FJK	Class II	1980-11-25
K802819	Ketac-Cem in Ref. to K802048	Espe Dental Products	EMA	Class II	1980-11-24
K802811	Monoject Root Canal Filling Mat. Needle	Sherwood Medical Co.	DZM	Class I	1980-11-24
K802800	Narco Air-Sheilds Sys. 100 Monitor Sys	Narco Air-Shields	DXG	Class II	1980-11-24
K802796	Cellamin	Secol Co.	ITG	Class I	1980-11-24
K802764	Plastic Adhesive Bandage	Dyn-A-Med Products	KGX	Class I	1980-11-24
K802684	Heliomat	Vivadent (USA), Inc.	EAY	Class I	1980-11-24
K802683	Heliosit	Vivadent (USA), Inc.	EBF	Class II	1980-11-24