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 2259 of 3531

510(k) clearances, page 2259 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932511	Silicone Mirror	Moyco Industries, Inc.	EKJ	Class I	1993-11-05
K932467	Ilab 900/1800 Clinical Chemistry System	Instrumentation Laboratory Co.	JJQ	Class I	1993-11-05
K932274	Integral III Dental Implant Abutment	Calcitek, Inc.	DZE	Class II	1993-11-05
K931906	New Stachrom Protein C Test Kit	American Bioproducts Co.	GGP	Class II	1993-11-05
K931698	Kings Bay Prelude One Step Hcg Combo Kit	King'S Bay Intl., Inc.	JHI	Class II	1993-11-05
K931597	Carapace Incision and Drainage Trays	Carapace, Inc.	MCZ	Class I	1993-11-05
K931443	Ortho*epstein-Barr Virus Ea(d+r)-Igg Antibody Elis	Ortho Diagnostic Systems, Inc.	LSE	Class I	1993-11-05
K931183	Glycohemoglobin	Teco Diagnostics	LCP	Class II	1993-11-05
K931080	Amylase Reagent Set (Kinetic)	Teco Diagnostics	JFJ	Class II	1993-11-05
K925392	Biopsy Forceps	Endo-Therapeutics, Inc.	FCL	Class I	1993-11-05
K925351	Synthes(u.s.a.) Anterior Spinal Plate	Synthes (USA) Products LLC	KWQ	Class II	1993-11-05
K923636	Trocar W/ Blunt Tip Obturator	Applied Medical Resources Corp	HET	Class II	1993-11-05
K923562	Intergral III Dental Implant System	Calcitek, Inc.	DZE	Class II	1993-11-05
K933110	Olympus Guide Wire	Olympus Corp.	OCY	Class II	1993-11-04
K932529	Lightspeed Dental Hand Instrument	Lightspeed Endodontics	EKS	Class I	1993-11-04
K930610	Talc Dispenser Syringe	Nusurg, Inc.	KYZ	Class I	1993-11-04
K930171	Fst Dual, Dual Pressure Urodynamics Monitor	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1993-11-04
K930115	Perioglass	Usbiomaterials Corp.	LYC	Class II	1993-11-04
K930081	Ohmeda Adaptable Cable W/detachable Sensor	Ohmeda Monitoring Systems	DQO	Class II	1993-11-04
K923611	Ultra Thin Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	1993-11-04
K921713	Dental Root Canal Bacterialcidal Lubricant	A and V Ent.	KJJ	Unclassified	1993-11-04
K934585	Pro-Flo System with Infra-Red Remote Control	Lafayette Pharmaceuticals, Inc.	FCD	Class I	1993-11-03
K934566	Radassist	Diacor, Inc.	IYE	Class II	1993-11-03
K934481	Ep-X	Fischer Imaging Corp.	JAA	Class II	1993-11-03
K933700	Dye Management System	Abbott Medical	DQO	Class II	1993-11-03
K933589	Boehringer Mannheim Tina-Quant Transferrin Assay	Boehringer Mannheim Corp.	DDG	Class II	1993-11-03
K933493	Ram-Pacs	Medical Knowledge Systems, Inc.	IYE	Class II	1993-11-03
K933409	Impax 1000	Kulzer GmbH	LMD	Class I	1993-11-03
K933321	Deltamanager	Medimage, Inc.	KPS	Class II	1993-11-03
K933299	Ql Multipulse 2048	Infimed, Inc.	JAA	Class II	1993-11-03
K932016	Tracheostomy Care Tray	Clinipad Corp.	JOH	Class II	1993-11-03
K932012	Caps	Chemichl AG	ELL	Class II	1993-11-03
K931808	Duceragold, Duceratin	Degussa AG	ELL	Class II	1993-11-03
K931372	Resound Portable Prescriptive Programming System	Resound Corp.	ESD	Class I	1993-11-03
K931279	Acu-Ray	Sterne Equipment Co., Ltd.	IZL	Class II	1993-11-03
K931149	Ca-1000 Automated Coagulation Analyzer	Toa Medical Electronics USA, Inc.	JPA	Class II	1993-11-03
K931119	Durham; Non Coring Winged Administration Set	Intl. Medical Consultants	FPA	Class II	1993-11-03
K930974	Durham; Injection Site Extension Set, Luer Lock	Intl. Medical Consultants	FPA	Class II	1993-11-03
K930927	Durham;t Adaptor Extensionset W/injection Site	Intl. Medical Consultants	FPA	Class II	1993-11-03
K930579	Medison 88P Diagnostic Ultrasound Imaging Sytem	Medison America, Inc.	IYO	Class II	1993-11-03
K930041	Vicrosafe 6 and Vicrosafe 12	Buffalo Filter Co., Inc.	FYD	Class II	1993-11-03
K925418	Energized Container System	Abbott Medical	FPA	Class II	1993-11-03
K921989	Fdp - Slidex Direct	Biomerieux Vitek, Inc.	GHH	Class II	1993-11-03
K934309	Disco Sunglasses Nonprescription Sunglasses	U.S. Toy Co., Inc.	HQY	Class I	1993-11-02
K934308	Child Nonprescription Sunglasses	U.S. Toy Co., Inc.	HQY	Class I	1993-11-02
K934307	Butterfly Nonprescription Sunglasses	U.S. Toy Co., Inc.	HQY	Class I	1993-11-02
K934305	Aviator Nonprescription Sunglasses	U.S. Toy Co., Inc.	HQY	Class I	1993-11-02
K934304	Animal Nonprescription Sunglasses	U.S. Toy Co., Inc.	HQY	Class I	1993-11-02
K934249	Traction Productions Spectacle Frames	Traction Productions, USA	HQZ	Class I	1993-11-02
K933717	Olympus Measuring Devices	Olympus Corp.	FDS	Class II	1993-11-02