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 2179 of 3531

510(k) clearances, page 2179 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942830	Hae 3	Hearing Aid Express	ESD	Class I	1994-07-20
K942829	Hae 1	Hearing Aid Express	ESD	Class I	1994-07-20
K942774	Polyskin(r) M.r. Moist Responsive Transparent Dressing	The Kendal Co.	MGP	Unclassified	1994-07-20
K942503	Unicath Family	Angiographic Devices Corp.	IZI	Class II	1994-07-20
K942303	Tecnadyne T-Cuff	Technadyne Scientific, Inc.	KCY	Class I	1994-07-20
K942264	Ddr with Dpa and 30/60 Options (Digital Viewstation)	Eigen Video	JAA	Class II	1994-07-20
K941981	Axillobifemoral Gore-Tex Cascular Graft,bifurcated	W. L. Gore & Associates, Inc.	DSY	Class II	1994-07-20
K941921	Bio-Medicus Bio-Console Models 540, 540A,b,c,d,e, & 550	Medtronic Bio-Medicus, Inc.	DWA	Class II	1994-07-20
K941662	Gm Opti*cam Camera with ENT Fiber Optic Light	Gm Engineering, Inc.	EQH	Class I	1994-07-20
K941499	Kit Pak Dressing Change Tray	Kit Pak, Inc.	KGX	Class I	1994-07-20
K941475	Cronex Regular Cassette	Dupont Medical Products	IXA	Class II	1994-07-20
K941372	Cedia Dau Amphetamines Assay	Microgenics Corporation	DKZ	Class II	1994-07-20
K941363	Phantom	Dynarad Corp.	IZL	Class II	1994-07-20
K941314	Stanbio Alt/gpt (Luqui-UV) Test Set	Stanbio Laboratory	CKA	Class I	1994-07-20
K941221	Dupont Aca Plus Immunoassay System Follicle Stimulating Hormone	Dupont Medical Products	CGJ	Class I	1994-07-20
K941115	Acs Cardio-Trol Control	Analytical Control Systems	JJY	Class I	1994-07-20
K941063	DNA Triglyceride Procedure	Data Medical Associates, Inc.	JGY	Class I	1994-07-20
K940433	Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,g3,& G4	Medical Analysis Systems, Inc.	DIF	Class I	1994-07-20
K936313	Cms-90 Blood Pressure Measurement Assistant	Prevention Sciences	DXQ	Class II	1994-07-20
K935984	Glutamyl-Transferase, Procedure No. 419	Sigma Diagnostics, Inc.	JQB	Class I	1994-07-20
K935634	Wallach Leep Procedure Kit	CooperSurgical, Inc.	HGI	Class II	1994-07-20
K935232	Hydrotorque Guide Wire	Kingston Technologies, Inc.	DQX	Class II	1994-07-20
K934762	Opus Procainamide Test System	Pb Diagnostic Systems, Inc.	LAR	Class II	1994-07-20
K934733	Stimulating Surgical Instruments	Smith & Nephew Richards, Inc.	ETN	Class II	1994-07-20
K933465	Cosmet	Great Bay Medical Products, Inc.	KCZ	Class I	1994-07-20
K932429	Cordis Gravity Compensating Accessory	Cordis US Corp.	JXG	Class II	1994-07-20
K930680	Thermoscan Instant Thermometer Ir-5000	Thermoscan, Inc.	FLL	Class II	1994-07-20
K921294	Video Endoscope-Rigid Modification	Medical Dynamics, Inc.	HET	Class II	1994-07-20
K942957	O-R-Ez Tip Cleaner	O-R-Ez, Inc.	GEI	Class II	1994-07-19
K942896	Clamps and Clips	Surgin Surgical Instrumentation, Inc.	MDM	Class I	1994-07-19
K942886	Simpulse Solo Suction Irrigator	Davol Inc., Sub. C.R. Bard, Inc.	FQH	Class II	1994-07-19
K942879	Deroyal Surgical's Endoscopic Specimen Retrieval Pouch	DeRoyal Industries, Inc.	GCJ	Class II	1994-07-19
K942691	Lorrex Post Operative Sponges	Lorons International Corp.	EFQ	Unclassified	1994-07-19
K942526	Sure-Closure II 75Mm Skin Stretching System	Life Medical Sciences, Inc.	MKY	Class I	1994-07-19
K942356	Med-Evac-4 Medical Evacuation Stretcher	Montery Bay Corp.	FPP	Class I	1994-07-19
K941984	Sabratek 6060 Homerun Volumetric Infusion Pump	Sabratek Corp.	FRN	Class II	1994-07-19
K941932	Splash Mask	Incon Diversified Industries, Inc.	LYU	Class I	1994-07-19
K940971	Ames Dca 2000 Hemoglobin Alc Controls	Kulzer GmbH	LCP	Class II	1994-07-19
K940840	Act Control Set	Sigma Diagnostics, Inc.	JPA	Class II	1994-07-19
K936016	Quantikine IVD Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)	R & D Systems, Inc.	GGT	Class II	1994-07-19
K935820	Kolster Methods	Kolster Methods	HGH	Class II	1994-07-19
K934286	Hysteroscope	Bei Medical Systems Co., Inc.	HIH	Class II	1994-07-19
K934049	Bii-Pore(tm) Canal Wall Prosthesis	Bio-Interfaces, Inc.	LYC	Class II	1994-07-19
K933762	Stb Yankauer Sucker/nozzle	Save-T-Breath Distributors C.C.	JOL	Class II	1994-07-19
K933688	Bii-Pore	Bio-Interfaces, Inc.	LYC	Class II	1994-07-19
K933624	Vitalmax 4000	Pace Tech, Inc.	MHX	Class II	1994-07-19
K932203	Vitalmax 530	Pace Tech Medical Monitors, Inc.	DQA	Class II	1994-07-19
K926412	Micron-Scope II	Chiron Vision Corp.	HMS	Class I	1994-07-19
K925098	Biofix Absorbable Self-Reinforced Poly-L-Lactide	Bioscience, Inc.	HTY	Class II	1994-07-19
K942876	Implantech Dorsal Nasal Implant	Implantech Associates Inc	FZE	Class II	1994-07-18