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 2052 of 3531

510(k) clearances, page 2052 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953236	Cylinder Implants Ha, Tp, Grade 3	Implant Center of the Palm Beaches	DZE	Class II	1995-09-13
K953235	Screw Implants, Grade 3; Uncoated, Ha, Tp-K3	Implant Center of the Palm Beaches	DZE	Class II	1995-09-13
K953139	Kis-- Four Hole Cylinder	Implant Center of the Palm Beaches	DZE	Class II	1995-09-13
K953110	Low Profile Titanium Model Catalog #1003	Therex Corp.	LJT	Class II	1995-09-13
K953033	Prime Cemented Small Femoral Stem	Orthopaedic Innovations, Inc.	JDI	Class II	1995-09-13
K953004	Dilatation Catheter, Balloon	Boston Scientific Corporation	EZN	Class II	1995-09-13
K952610	Plexus/3000 (P/3000), Plexus/3500 (P/3500)	Plexus Medical	FNM	Class II	1995-09-13
K951948	Kodak Xls 8600 (Ps)	Kodak Health Imaging Systems, Inc.	LMC	Class II	1995-09-13
K951807	Kodak Ektascan Triad Laser Printer System, Photon Laser Printer	Kodak Health Imaging Systems, Inc.	LMC	Class II	1995-09-13
K950682	W2 Wrist Cpm Unit	Toronto Medical Corp.	BXB	Class I	1995-09-13
K950479	Disposable ECG Monitoring Electrode #4600 60Mm, #4610 45Mm	Nikomed U.S.A., Inc.	DRX	Class II	1995-09-13
K950349	Dynatron 950	Dynatronics Corp.	LIH	Class II	1995-09-13
K950348	Dynatron 650	Dynatronics Corp.	LIH	Class II	1995-09-13
K954155	Greene, Turner, Menghini Style Aspiration Biopsy Needle	Promex, Inc.	FCG	Class II	1995-09-12
K954075	Yeou Nan Sunglasses Frame Mfg, Co., Ltd.	Yo Nan Sunglasses Co., Ltd.	HQY	Class I	1995-09-12
K953993	Tympasnostomy Tube	Hampton Precision Products, Inc.	ETD	Class II	1995-09-12
K953989	Sunglasses	Morris & Sons Co.	HQY	Class I	1995-09-12
K953960	Hearing Aid (All-in-the-Ear)	Audina Hearing Instrument, Inc	ESD	Class I	1995-09-12
K953947	Sunglasses	Wenzhou Yian Optical International, Co., Ltd.	HQY	Class I	1995-09-12
K953920	Revert Sunglasses & Polar Sunglasses	Bella Occhiali, Inc.	HQY	Class I	1995-09-12
K953918	Magnetic Resonance Diagnostic Device	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1995-09-12
K953832	Solarix Fv	GE Healthcare	KPR	Class II	1995-09-12
K953782	Nil	Dehang Industries, Ltd.	HQY	Class I	1995-09-12
K953729	K Amp Full Shell and in the Ear	Midwest City Hearing Aid Center	ESD	Class I	1995-09-12
K953728	Rx12 Linear Full Shell and in the Canal	Midwest City Hearing Aid Center	ESD	Class I	1995-09-12
K953528	Roche Cobas-Fp Reagents for Vancomycin	Roche Diagnostic Systems, Inc.	LEH	Class II	1995-09-12
K953376	Access Point	Access Surgical Intl., Inc.	GCJ	Class II	1995-09-12
K953348	Articulating Retractor Tissue Retractors	Gm Engineering, Inc.	GCJ	Class II	1995-09-12
K953114	Evolution Microcatheter	Boston Scientific Corporation	DQO	Class II	1995-09-12
K953072	Merocel Vaginal Pack	Merocel Corp.	EFQ	Unclassified	1995-09-12
K952963	Sunglasses & Sport Sunglasses	Wenzhou Winsor Optical International Co., Ltd.	HQY	Class I	1995-09-12
K952864	Bair Hugger Model 655 Blanket	Augustine Medical, Inc.	DWJ	Class II	1995-09-12
K952856	Light-Cure Pc	Midwest Orthodontic Mfg.	DYH	Class II	1995-09-12
K952697	Titanium Classic Compression Hip Screw System	Smith & Nephew Richards, Inc.	HWC	Class II	1995-09-12
K952597	View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun Pockets, Point of View	Point of View Optical Outlet, Inc.	HQZ	Class I	1995-09-12
K952438	Sunglasses (Non-Prescription Including Photosensitive)	Taiwan Eva Industrial Co., Inc.	HQY	Class I	1995-09-12
K952034	Medela's Foot Pump	Medela AG	HGY	Class I	1995-09-12
K951712	Hearing Aid (All-in-the-Ear)	Omega Hearing Aid Center	ESD	Class I	1995-09-12
K946094	Cadwell Easy Ambulatory EEG	Cadwell Laboratories, Inc.	GWQ	Class II	1995-09-12
K945678	Datacell 18Ms	Danam Electronics	GKZ	Class II	1995-09-12
K945498	Instent Endocoil-T(tm) Transhepatic Biliary Endoprosthesis	Instent, Inc.	FGE	Class II	1995-09-12
K945265	Optus Hysteroscopes and Contact Hysteroscopes	Optus, Inc.	HIH	Class II	1995-09-12
K943717	Master-Neb Nebulizer Compressor System	Howard K. Mann & Assoc.	CAF	Class II	1995-09-12
K940473	Enterovirus 71 Monoclonal Antibody	Chemicon Intl., Inc.	GOE	Class I	1995-09-12
K940034	Poliovirus 2 Monoclonal Antibody	Light Diagnostics	GOE	Class I	1995-09-12
K940027	Enterovirus Blend Monoclonal Antibodies	Chemicon Intl., Inc.	GOE	Class I	1995-09-12
K940026	Poliovirus Blend Monoclonal Antibodies	Light Diagnostics	GOE	Class I	1995-09-12
K940017	Poliovirus 3 Monoclonal Antibody	Light Diagnostics	GOE	Class I	1995-09-12
K954011	Fascia Closure Device	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-09-11
K953622	Ptt 6200 Elevation Therapy Table	U.S. Table, Inc.	INQ	Class I	1995-09-11