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 2892 of 3529

510(k) clearances, page 2892 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862125	Arizona Condylar Tibial Plateau	Depuy, Inc.	HRY	Class II	1986-06-27
K862060	Polypectomy Snare	Endovations	KNS	Class II	1986-06-27
K862006	Stand & High Flow Femoral-Ventricular Pigtail Cath	Cordis US Corp.	DQO	Class II	1986-06-27
K862002	Medisystems Pheresis Needle	Medisystems Corp.	FIE	Class II	1986-06-27
K861998	Total Bilirubin Test Kit	Ciba Corning Diagnostics Corp.	CIG	Class II	1986-06-27
K861972	Dermistrip	Kells Medical, Inc.	NAD	Class I	1986-06-27
K861926	Worthington Hdl Precipitating Reagent Set	Cooper Biomedical, Inc.	LBR	Class I	1986-06-27
K861832	Rich-Mar Spina-Mobilizor	Rich-Mar Corp.	ITH	Class II	1986-06-27
K861793	Twin Triglycerides Gpo/cholesterol	Boehringer Mannheim Corp.	CDT	Class I	1986-06-27
K861775	Twin Bun/glucose	Boehringer Mannheim Corp.	CDW	Class II	1986-06-27
K861680	Osteonics Elbow Prosthesis	Osteonics Corp.	JDC	Class II	1986-06-27
K861635	Triglycerides Gpo-Trinder	Catachem, Inc.	CDT	Class I	1986-06-27
K861580	Progroup (Tm) Automated Liquid Handling System	Cetus Corp.	JQW	Class I	1986-06-27
K861403	Tb Series Bipolar Pacing Leads	Oscor Medical Corp.	LDF	Class II	1986-06-27
K861387	Kodak Ektachem Clinical Chemistry Slides (Ck-Mb)	Eastman Kodak Company	JHS	Class II	1986-06-27
K861361	Estradiol Maia Ria Kit Magnetic Separation Phase	Serono Diagnostics, Inc.	CHP	Class I	1986-06-27
K861271	Sucrosep Human Prolactin (Hpr) Irma	Boots-Celltech Diagnostics, Inc.	CFT	Class I	1986-06-27
K860664	Cresolphthalein Complexone, Calcium	Amresco, Inc.	CIC	Class II	1986-06-27
K860085	Lyofoam Wound Dressings	Acme United Corp.	NAD	Class I	1986-06-27
K862242	Pap Smear Kit	Quali-Med, Inc.	HHT	Class II	1986-06-26
K862095	Model Ca, Hearing Aid	Fine-Tune	ESD	Class I	1986-06-26
K861956	Jeltrode	Henley Intl.	GXY	Class II	1986-06-26
K861846	Hydron Root Canal Filling & Mark IV Starter Kit	Solar Dental Co., Inc.	EIC	Class I	1986-06-26
K861502	Eoh 8501 Osseointegrated Implant System	Dr. Harold Bergman	DZE	Class II	1986-06-26
K861428	Suction Control Valve (Nonadjustable) Cat.rlv-2100	American Omni Medical, Inc.	DWD	Class II	1986-06-26
K861422	Pacesetter/siemens Pulse Genera W/vs-1 Head Cavity	Pacesetter Systems	DXY	Class III	1986-06-26
K860846	Cordis Hi-Flex Pervenous Bipolar Lead	Cordis US Corp.	DTB	Class III	1986-06-26
K860673	Oxygenator Model Nos. Bentley-10A & Bentley-10B	American Bentley	DTZ	Class II	1986-06-26
K860264	Scherer Portable Tooth Polisher	Scherer Laboratories, Inc.	JEQ	Class I	1986-06-26
K860239	Org-7201 Multiparameter Telemetry Monitor	Nihon Kohden America Inc	DRG	Class II	1986-06-26
K853555	Fast Formalert	bioMerieux, Inc.	KOC	Class II	1986-06-26
K862209	Alt (Sgpt) Reagent Set (UV Rate)	Sterling Diagnostics, Inc.	CKA	Class I	1986-06-25
K862144	X-Mat	Combined Concepts, Inc.	KXJ	Class II	1986-06-25
K862133	Hygeia Rapid Strep a Test	Hygeia Sciences	GTY	Class I	1986-06-25
K862114	Khuri Regional Tissue Ph Monitor	Vascular Technology Incorporated	CBZ	Class II	1986-06-25
K861963	Ultralite Hf1236 Hand and Foot System	Ultralite	FTC	Class II	1986-06-25
K861899	Scotchbond Light Cured Dental Adhesive W/fluoride	3M Company	EBF	Class II	1986-06-25
K861891	Tobramycin (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	JIS	Class II	1986-06-25
K861796	Fittronic	Corleone Intl. Traders, Inc.	IPF	Class II	1986-06-25
K861770	Phenytoin (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	JIS	Class II	1986-06-25
K861769	Gentamicin (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	JIS	Class II	1986-06-25
K861768	Theophylline (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	JIS	Class II	1986-06-25
K861671	Direct Bilirubin Procedure	Data Medical Associates, Inc.	CIG	Class II	1986-06-25
K861503	Companion Liquid Oxygen System	Medtronic, Inc.	BYJ	Class II	1986-06-25
K861475	Assera-Plate Protein C Kit	American Bioproducts Co.	GGP	Class II	1986-06-25
K861417	Assera-Plate Vwf Kit	American Bioproducts Co.	GGP	Class II	1986-06-25
K861366	Alt-30, 60 and 100	Dimension Diagnostics	CKA	Class I	1986-06-25
K861274	Double Antibody Calcitonin Ria Kit	Siemens Healthcare Diagnostics Inc.	JKR	Class II	1986-06-25
K860136	Bard-Parker Carotid Shunt	BD Becton Dickinson Vacutainer Systems Preanalytic	DWF	Class II	1986-06-25
K854030	Wrist Actigraph	Ambulatory Monitoring, Inc.	GWQ	Class II	1986-06-25