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 2026-11-02, 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 2399 of 3531

510(k) clearances, page 2399 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K912859	Fujinon Evl-F	FUJIFILM Healthcare Americas Corporation	GCJ	Class II	1992-01-23
K915708	Inorganic Phosphorus(colorimetric) Reagent Set	Tech Intl. Co.	CEO	Class I	1992-01-22
K915540	Model 3587A Resume II Lead	Medtronic, Inc.	GZF	Class II	1992-01-22
K915533	Quickie Carbon Wheelchair	Sunrise Medical Quickie Designs, Inc.	IOR	Class I	1992-01-22
K915376	Glasion Varnish	Sci-Pharm Scientific Pharmaceutical, Inc.	FMC	Class I	1992-01-22
K915284	Stacking Microplate Washer	Denley Instruments, Inc.	JQW	Class I	1992-01-22
K915231	Epidural Indication for Volumetric Infusion Pumps	Q-Life Systems, Inc.	FRN	Class II	1992-01-22
K915180	Opiate Eia Assay	Diagnostic Reagents, Inc.	DJG	Class II	1992-01-22
K914915	Microline Screen for Cannabinoid	Drug Screening Systems, Inc.	LDJ	Class II	1992-01-22
K914909	Il Test(tm) Calibration Set Sp	Instrumentation Laboratory Co.	JIX	Class II	1992-01-22
K914113	Angiographic Flush System	E-Z-EM, Inc	FPA	Class II	1992-01-22
K914084	Endoscopes	Precise Optics	GCJ	Class II	1992-01-22
K913934	Medtronic Model 3586 Resume Lead	Medtronic, Inc.	GZB	Class II	1992-01-22
K913439	Sonix...therapeutic Sonic Massage	Mcshirley Products, Inc.	IRO	Class I	1992-01-22
K913256	Derma-Lase Ruby Laser - Model Dlr-1	Derma-Lase Co.	GEX	Class II	1992-01-22
K911722	Oscillomate (Tm) Blood Pressure Monitor-Model 1630	Cas Medical Systems, Inc.	DXN	Class II	1992-01-22
K904243	Tsrh Variable Angle Sacral Screw	Danek Medical, Inc.	KWP	Class II	1992-01-22
K920024	Rihards Titanium Half Pin	Smith & Nephew Richards, Inc.	KTT	Class II	1992-01-21
K915659	Three Wheel Scooter	Pride Health Care, Inc.	INI	Class II	1992-01-21
K915335	Silicoater System	Kulzer GmbH	EBF	Class II	1992-01-21
K915243	Touch 'N Heat Model 5002, Modification	Analytic Technology	EKM	Class I	1992-01-21
K915062	Dohlman Doane Keratoprothesis	Mackeen Consultants, Ltd.	HQM	Class II	1992-01-21
K914980	Hex, Quad, or Rail Block Manifold Accessories	Medical Fittings, Inc.	BYX	Class I	1992-01-21
K913915	Bard(r) William Harvey(r) Macro Filt Cardio Reserv	Bard Cardiosurgery Div	DTN	Class II	1992-01-21
K913542	Thoracic Catheter with Guide	Intl. Medical Devices, Ltd.	GBX	Class I	1992-01-21
K913539	Thoracic Cathter Stylet	Intl. Medical Devices, Ltd.	GBX	Class I	1992-01-21
K913527	Hyperfree	Kist Intl.	BYO	Class I	1992-01-21
K912054	Labor Delivery Tray	Medical Device Inspection Company	HFW	Class II	1992-01-21
K915818	Synthes(r) Titanium Small Reconstruction Plate	Synthes (USA) Products LLC	HRS	Class II	1992-01-17
K915602	Sri Digoxin Enzyme Immunoassay	Serono-Baker Diagnostics, Inc.	KXT	Class II	1992-01-17
K915541	Spect Table, Model #056-760	Atomic Products Corp.	IYZ	Class I	1992-01-17
K915431	Complement C1 Inactivator Kit	The Binding Site	DBA	Class II	1992-01-17
K915398	Tdr-5 Binaural Hearingaid/wireles Fm Receiver	Telex Communications, Inc.	EPF	Class II	1992-01-17
K915397	Tdr-7 Binaural Hearing Aid/wireless Fm Reciever	Telex Communications, Inc.	EPF	Class II	1992-01-17
K915384	Tdr-4S Monaural Hearing Aid/wireless Fm Receiver	Telex Communications, Inc.	EPF	Class II	1992-01-17
K915383	Tdr-4 Monaural Hearing Aid/wireless Fm Receiver	Telex Communications, Inc.	EPF	Class II	1992-01-17
K915095	Estiseal Lc	Kulzer GmbH	EBC	Class II	1992-01-17
K915071	Differential Counting Board	Biovation, Inc.	GKZ	Class II	1992-01-17
K914993	Il Test(tm) Transferrin (Trf)	Instrumentation Laboratory Co.	DDG	Class II	1992-01-17
K914824	Hypoallergenic Surgeon's Gloves - Sterile	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1992-01-17
K914766	Sun Sight Sunglasses/sun Sight Reading Glasses	Sun Sight Glasses Co., Ltd.	HQY	Class I	1992-01-17
K914764	Stern Era Implant Abutment	Sterngold/Implamed	DZE	Class II	1992-01-17
K914760	Latex Examination Gloves	Ansell, Inc.	LYY	Class I	1992-01-17
K914735	Ventricular Pressure Monitoring Kit, Model 110-4Hm	Camino Laboratories, Inc.	GWM	Class II	1992-01-17
K914727	Sequence Light Cure Adhesive	Ormco Corp.	DYH	Class II	1992-01-17
K914437	Correct-S.i.m.	Jeneric/Pentron, Inc.	ELW	Class II	1992-01-17
K913956	Blood Cardioplegia Heat Exchanger, Model #He-30	Bentley Laboratories, Inc.	DTN	Class II	1992-01-17
K913949	True/flex Humerus, Ulna & Radius Intramed Rods Sys	Applied Osteo Systems, Inc.	HSB	Class II	1992-01-17
K912632	Occlude	Pascal International, Inc.	EFH	Class I	1992-01-17
K911270	Leocor Guiding Catheter	Leocor, Inc.	DQO	Class II	1992-01-17