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 2162 of 3531

510(k) clearances, page 2162 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943398	The Blendtone Royale	Instantron	KCW	Class I	1994-09-16
K943396	The Elite Spectrum	Instantron	KCW	Class I	1994-09-16
K943340	Cordis Steerable Guidewire	Cordis US Corp.	DQX	Class II	1994-09-16
K943318	All-in-the-Ear	Golden State Audiology Assoc.	ESD	Class I	1994-09-16
K942904	Stabilet	Hill-Rom Inc.	FMT	Class II	1994-09-16
K942860	Visionlink Dicom Module	Evergreen Technologies, Inc.	KPS	Class II	1994-09-16
K942786	Karl Storz Laser Accessories	Karl Storz Endoscopy-America, Inc.	GEX	Class II	1994-09-16
K942363	Cequal-Quantitative Analysis	Nuccardiac Software, Inc.	KPS	Class II	1994-09-16
K942355	Model #310T03500 Wrist Coil	Medic, Inc.	LNH	Class II	1994-09-16
K941920	Interacoustics Clinical Audiometer	Precision Acoustics Ind., Inc.	EWO	Class II	1994-09-16
K941600	Mt-300 Cassette Holder	Medtec LLC	IXA	Class II	1994-09-16
K941273	Innovasive Arthroscopic Roc Suture Bone Fastener	Innovasive Devices, Inc.	HRX	Class II	1994-09-16
K940996	Olympic Bili-Lite	Olympic Medical Corp.	LBI	Class II	1994-09-16
K940206	Bard Urine Collection Products Modification	C.R. Bard Inc	KNX	Class II	1994-09-16
K936142	3M 1154 Laser Imager	3M Information,Imaging and Electronic Sector	LMC	Class II	1994-09-16
K935955	Doser	Newmed Inc	CAF	Class II	1994-09-16
K935617	Arthro-Flo Irrigation System Modification	Davol Inc., Sub. C.R. Bard, Inc.	HRX	Class II	1994-09-16
K935520	Upper Body Cycles (110 Volt)/(220 Volt)	Sport Medical Technology Inc	BXB	Class I	1994-09-16
K935277	Karl Storz Hopkins (Ksh) I Rigid Telescope, Ksh II Rigid Telescope, Ksh Rigid Operating Scopes Karl Storz Oval Sheath	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-09-16
K935216	Semi-Recumbent Cycles	Sport Medical Technology Inc	BXB	Class I	1994-09-16
K935061	Lower Body Cycles	Sport Medical Technology Inc	BXB	Class I	1994-09-16
K935052	Microline Screen for Amphetamine	Drug Screening Systems, Inc.	DKZ	Class II	1994-09-16
K934987	Cp-Spine Coils for Gyrex 2T-Dlx & V-Dlx	Elscint, Inc.	LNH	Class II	1994-09-16
K933454	Dynamic Germicidal Air Purification System	L&H Airco	FRA	Class II	1994-09-16
K931902	Cusa System 200C/t Ultrasonic Aspirator & Access.	Medtronic, Inc.	LFL	Unclassified	1994-09-16
K924685	Stp Complete Module Set and Mask Fixation System	Leibinger GmbH	IYE	Class II	1994-09-16
K935233	Iolab Lacrimal Duct Catheter	Chiron Vision Corp.	OKS	Unclassified	1994-09-15
K931071	Philips Thoravision	Philips North America LLC	KPR	Class II	1994-09-15
K922102	Proportional Solenoid Valve	Medtronic, Inc.	CBK	Class II	1994-09-15
K944109	Nil	Keep Top Intl., Ltd.	HQY	Class I	1994-09-14
K944108	Nil	Micron Metal & Plastic Manufactory Co.	HQY	Class I	1994-09-14
K944107	Vip Plus Percutaneous Introducer	Greatbatch Medical	DYB	Class II	1994-09-14
K944026	Mirage Eyewear Inc.	Mirage Eyewear, Inc.	HQY	Class I	1994-09-14
K943963	Nil	Max-Vision (H.K.)Limited	HQY	Class I	1994-09-14
K943792	Spectacle Frames	Kt Optique, Inc.	HQZ	Class I	1994-09-14
K943786	Portland Trocars	Mikroland Micromecanique	GCJ	Class II	1994-09-14
K943754	Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product	Bionostics, Inc.	JJY	Class I	1994-09-14
K943704	Lipase Calibrator	The du Pont Co.	JIT	Class II	1994-09-14
K943697	Trocars,cannulae,sheaths,obturators	Karl Storz Endoskop GmbH	ODB	Class II	1994-09-14
K943641	Spectacle Frame	Australian Optical Co., Inc.	HQZ	Class I	1994-09-14
K943640	Sunglass Clip	Australian Optical Co., Inc.	HQY	Class I	1994-09-14
K943562	Sunglasses	Australian Optical Co., Inc.	HQY	Class I	1994-09-14
K943561	Spectacle Frame	Australian Optical Co., Inc.	HQZ	Class I	1994-09-14
K943376	Opera System	Miles, Inc.	JJC	Class I	1994-09-14
K943296	Ilo Made in Italy; Garbo Hand Finished Italy	Ilo Industria Lombarda Ottica SRL	HQY	Class I	1994-09-14
K943290	Bilirubin Plus/pediatric Controls	Medi-Tech, Inc.	JJY	Class I	1994-09-14
K943047	IV Start Kits	Sterile Concepts, Inc.	KMK	Class I	1994-09-14
K942257	Doa-Plus, Drugs of Abuse Controls	Medical Diagnostic Technologies, Inc.	DIF	Class I	1994-09-14
K942041	Nida-5/Rt, Drug of Abuse Controls	Meditech	DIF	Class I	1994-09-14
K942009	Primus Rapid Gel 100 Glycated Hemoglobin Assay	Trinity Biotech (Primus Corporation dba Trinity Biotech)	LCP	Class II	1994-09-14