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 2271 of 3531

510(k) clearances, page 2271 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K933424	Stetson/s.loren/h.bazaar/g.vanderbilt/p.balmain	Zyloware LLC	HQZ	Class I	1993-09-20
K933423	Stetson/s.loren/lh.bazaar/g.vanderbilt/p.balmain	Thunder Industries, Inc.	HQZ	Class I	1993-09-20
K933254	Eyeglass Frames	Sam Chung Optical Co., Ltd.	HQY	Class I	1993-09-20
K933098	Medical Image Management System/x-Ray Terminal	Siemens Medical Solutions Health Services Corporat	LMD	Class I	1993-09-20
K933074	Sunglasses	P.T. Sun and Young Indonesia Sunglasses	HQZ	Class I	1993-09-20
K933023	Cervical Traction Strap	Cook (Canada), Inc.	KPR	Class II	1993-09-20
K932941	Sunglasses	Rayman Speco Co., Ltd.	HQY	Class I	1993-09-20
K932940	Sunglasses	Sun and Young Sunglasses Co., Ltd.	HQY	Class I	1993-09-20
K932939	Sunglasses	Soft-Ray Optical Corp.	HQY	Class I	1993-09-20
K932814	Non-Prescription Suglasses	Sun Style Intl. Corp.	HQY	Class I	1993-09-20
K932794	Pulpdent Seal-Rite Low Viscosity	Pulpdent Corporation	EBC	Class II	1993-09-20
K932791	Pulpdent Edta Preparations	Pulpdent Corporation	KIF	Class II	1993-09-20
K932773	Frames, Spectacles	Diaco, Inc.	HQZ	Class I	1993-09-20
K932772	Frames, Spectacles	Optical Designs and Sourcing, Inc.	HQZ	Class I	1993-09-20
K932646	Rollens Post-Mydriatic Sunglass	Rollens Professional Products, Inc.	HQY	Class I	1993-09-20
K932319	Orthodontic Elastomer	Gac Intl., Inc.	ECI	Class I	1993-09-20
K931718	Spirit Shield	Eaton Medical Corp.	HQY	Class I	1993-09-20
K931717	Yoshida/kaycor X-707 Wall Mounted Dental X-Ray	Kaycor Intl., Ltd.	EAP	Class II	1993-09-20
K931504	Sunglasses	The B & F System, Inc.	HQY	Class I	1993-09-20
K931380	Water Pik Plus Plaque Control System	Teledyne Water Pik	EFS	Class I	1993-09-20
K930435	Spectacle Frames	Venis di A. Vendrame	HOI	Class I	1993-09-20
K926096	Non-Prescription Sunglasses	Lunettes Bondet	HQY	Class I	1993-09-20
K925864	Courier Pc	Shoreline Business Consulting	LMD	Class I	1993-09-20
K925428	Sunglasses	Dallas Handbag Co.	HQY	Class I	1993-09-20
K923006	As-90	Qualitone	ESD	Class I	1993-09-18
K932528	Olympus Chlorid Reagent, Modified	Olympus Corp.	CHJ	Class II	1993-09-17
K932300	Fog Control, Lens Fog Reduction Device	Highpoint Medical Corp.	OCT	Class II	1993-09-17
K931384	Ave Alliance Dilatation Catheter	Applied Vascular Engineering, Inc.	LIT	Class II	1993-09-17
K931282	Volume Transducer	Life-Tech Intl., Inc.	EXQ	Class II	1993-09-17
K925659	U.c.e.z. Lens Cleaner Kit	Anago, Inc.	OCT	Class II	1993-09-17
K925402	Oscillomate Blood Pressure Monitor-Model 9300	Cas Medical Systems, Inc.	DXN	Class II	1993-09-17
K933170	Inman Poole Tip Suction Probe W/tubing Kit	Inman Medical Corp.	GCY	Class I	1993-09-16
K931095	Spring Loaded Syringe	Acacia, Inc.	FMF	Class II	1993-09-16
K930713	The Infant Flow System	Sechrist Industries Inc	CAI	Class I	1993-09-16
K930674	Model 640Ge-64: Quadrature Pelvic Coil	Medical Advances, Inc.	LNH	Class II	1993-09-16
K930227	Ms Disposable Rigid Doppler Probe	Meadox Medicals, Div. Boston Scientific Corp.	DPW	Class II	1993-09-16
K926351	Colormark(tm) Visualization System	Echocath, Inc.	IYN	Class II	1993-09-16
K925775	Branemark System Machine Inst. Acc. to Drilling Eq	Nobelpharma USA, Inc.	DZE	Class II	1993-09-16
K925774	Branemark System Hand Instrument	Nobelpharma USA, Inc.	DZE	Class II	1993-09-16
K925772	Branemark System Guide Pins	Nobelpharma USA, Inc.	DZE	Class II	1993-09-16
K925770	Branemark System Drills and Countersinks	Nobelpharma USA, Inc.	DZE	Class II	1993-09-16
K925768	Branemark System Screw Tap	Nobelpharma USA, Inc.	DZE	Class II	1993-09-16
K925591	Meridian Medical Systems Hyper Inflation Bay Syst	Merit Medical Systems, Inc.	BZR	Class II	1993-09-16
K922670	The Minimed Model 404-Sp and 504-S	Medtronic, Inc.	FRN	Class II	1993-09-16
K914519	Diomed 25 Surgical Diode Laser, Gynecology Applic	Dio-Med Corp.	GEX	Class II	1993-09-16
K933052	Abuscreen Online(r) for Amphetamines, Modified	Roche Diagnostic Systems, Inc.	DKZ	Class II	1993-09-15
K933010	Biomerieux Hemolab Cofac VIII	Biomerieux Vitek, Inc.	GJT	Class II	1993-09-15
K932462	Vented Needle	Excel Medical, Inc.	LHI	Class II	1993-09-15
K932154	Conquest Crystal	Jeneric/Pentron, Inc.	EBF	Class II	1993-09-15
K932078	Helioseal F	Ivoclar North America, Inc.	EBC	Class II	1993-09-15