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 2188 of 3531

510(k) clearances, page 2188 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941295	Sharp II Helix Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1994-06-17
K941230	Mini-Ub Endoscopes	Candela Corporation	ODF	Class II	1994-06-17
K941211	Spectacle Frames	H & M Optical (U.S.A.), Ltd.	HQZ	Class I	1994-06-17
K941208	Diagnostic Sleeve, Reducer Sleeve	New Eder Corp.	HET	Class II	1994-06-17
K941095	Medsaver Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1994-06-17
K941061	Sunglasses	Kingmart Trading Co., Ltd.	HQY	Class I	1994-06-17
K940923	Sunglasses	Gbs Corp.	HQY	Class I	1994-06-17
K940733	Spectacle Frames (V.i.p. Int'l)	Continental Optical Imports	HQZ	Class I	1994-06-17
K940084	Model 2000 Ophthalmic Surgical System	Medical Technical Products, Inc	HQC	Class II	1994-06-17
K935997	Platinum Plus Guidewire	Boston Scientific Corporation	DQX	Class II	1994-06-17
K935949	Stryker 5000	Stryker Medical	FNM	Class II	1994-06-17
K934817	Surgical Design Corporation Model 700 Low Pressure Mattress	Surgical Design Inc	FNM	Class II	1994-06-17
K934252	Rppi Sterilization Bags	Royal Precision Plastics, Inc.	KCT	Class II	1994-06-17
K933748	Surgical Face Masks Plus Anti-Fog Shield	Bam Corp., Ltd.	FXX	Class II	1994-06-17
K932847	Corpak Enteral Pump	Corpak Co.	FRN	Class II	1994-06-17
K931861	Aid, Promise Powder Free Latex Examination Gloves	Taiping Super Holdings Sdn Bhd	LYY	Class I	1994-06-17
K931477	Amerse	Calgon Vestal Div.	LRJ	Class I	1994-06-17
K930072	Steritube	Jordco, Inc.	KCT	Class II	1994-06-17
K923168	Dual Port Enteral Y-Adaptor	Orion Life Systems, Inc.	KNT	Class II	1994-06-17
K942596	Alpha-Lock or Pro-Lock Fluoride Releasing Glass Ionomer Band Cement	Wallace A. Erickson & Co.	EMA	Class II	1994-06-16
K942557	Argesol-1060W	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942540	Argesol-Wg	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942539	Argesol-Lite	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942538	Argesol-1040Y	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942507	Argesol-Y	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942505	Argesol-Wsf Pre-Solder for High Gold Dental Procelain Alloys	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942462	Argesol-Ysf Pre-Solder for Hi Gold Dent Porcel Alloys	Argen Precious Metals, Inc.	EJT	Class II	1994-06-16
K942209	Liquichek Hematology-16 Control, Low, Normal and High	Bio-Rad	JCN	Class II	1994-06-16
K941912	N/t Protein Control Sy/l, M, and H	Behring Diagnostics, Inc.	JJY	Class I	1994-06-16
K941209	My Beat Powered Toothbrush	Sanwa Components USA, Inc.	JEQ	Class I	1994-06-16
K941065	Deox, Oxygen Barrier Viscous Solution	Ultradent Products Inc.	EMA	Class II	1994-06-16
K940502	Fresh Frozen Cells	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1994-06-16
K936207	Endo-Needle Instrument	Gerard Medical, Inc.	GDM	Class I	1994-06-16
K935185	Morphometric Total Hip Prosthesis	Landos, Inc.	LZO	Class II	1994-06-16
K935013	Dsl Estrone (Dsl 8700)	Diagnostic Systems Laboratories, Inc.	CGF	Class I	1994-06-16
K933968	Ace Pelvic Stabilizer	Ace Medical	JEC	Class II	1994-06-16
K931519	Acufex Suretac	Acufex Microsurgical, Inc.	JDR	Class II	1994-06-16
K931253	Quickanchor II	Mitek Surgical Products, Inc.	JDR	Class II	1994-06-16
K942437	Premier	Premier Medical Industries, Inc.	LYY	Class I	1994-06-15
K942323	Ongard 2 Gallon Sharps Container	Ongard Systems, Inc.	FMI	Class II	1994-06-15
K942075	Vector Power Wheelchair	Vector Mobility, Inc.	ITI	Class II	1994-06-15
K941926	Medi Strumpf	Medi USA, LP	DWL	Class II	1994-06-15
K940775	Injection Cap	Medron, LLC	FOZ	Class II	1994-06-15
K940662	I-5000	Support Systems Intl.	IOQ	Class II	1994-06-15
K940098	Beltone Invisa	Beltone Electronics Corp.	ESD	Class I	1994-06-15
K936214	Cs-Plus Stem	Encore Orthopedics, Inc.	JDI	Class II	1994-06-15
K932935	Titan Dysplasic Total Hip Prosthesis	Landos, Inc.	LZO	Class II	1994-06-15
K930876	Silicone Bipolar Lead Models 1136T, 1142T &1146T	Siemens-Pacesetter, Inc.	DTB	Class III	1994-06-15
K930480	Variable Angular Hold Bone Plate System	Smith & Nephew Richards, Inc.	HRS	Class II	1994-06-15
K921733	Tracheostomy Care Tray	Medikmark, Inc.	JOH	Class II	1994-06-15