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 2279 of 3531

510(k) clearances, page 2279 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926410	Ultratone 8+ & 20	Bowater Research, Inc.	IPF	Class II	1993-08-11
K926119	Exel Huber Infusion Set Rotating Wing	Exel Intl.	FPA	Class II	1993-08-11
K925117	Uresil Abscess Drianage and Irrigation Set	Uresil, LLC	GBX	Class I	1993-08-11
K933416	Devmed Lap Wash Reusable Endoscopic Lens Wash Sheath	Devmed Corp.	GCJ	Class II	1993-08-10
K933118	Remel Clarithromycin 15 Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1993-08-10
K932604	Unigrip-Fh Surgical Handpiece/laparoscopic	Unisurge, Inc.	GCJ	Class II	1993-08-10
K932424	Ana Profile I	Apotex Scientific, Inc.	LJM	Class II	1993-08-10
K932228	Microvasive Insurg Chloangiographic Catheter	Boston Scientific Corporation	GBZ	Class I	1993-08-10
K932018	Out for Fun! Happy Meal Mcdonaldland Sunglasses	Simon Marketing, Inc.	HQY	Class I	1993-08-10
K931912	Irrigating Blunt Dissector	Mayaguez Medical Center	KYZ	Class I	1993-08-10
K931856	5.0 Mm Irrigation/aspiration Probe	Mayaguez Medical Center	GCY	Class I	1993-08-10
K931854	Endoscopic Blunt Dissecting Instrument	Mayaguez Medical Center	FGS	Class II	1993-08-10
K931749	Bivona(r) ICU Endotracheal Tube	Bivona Medical Technologies	BTR	Class II	1993-08-10
K931328	Pyramid Sunglasses/pyramid Reading Glasses	Pyramid	HOI	Class I	1993-08-10
K930987	Crithidia Lucilliae Ds DNA Kit (Diagnostic Use)	The Binding Site	KTL	Class II	1993-08-10
K930809	Unitips	Unisurge, Inc.	GCJ	Class II	1993-08-10
K930459	Bard Mini-Infuser 1500 & 3000	Bard Medsystems Div.	FRN	Class II	1993-08-10
K926173	Staph-a-Lex(tm) System	Trinity Laboratories, Inc.	JWX	Class I	1993-08-10
K925917	Unichannel(tm Surgical Grasper	Unisurge, Inc.	GCJ	Class II	1993-08-10
K925882	Unitips Surgical Instruments	Unisurge, Inc.	GCJ	Class II	1993-08-10
K925743	Nasal Dorsum	Smith & Nephew Richards, Inc.	FZE	Class II	1993-08-10
K924689	Ubi Magiwel(tm) Helicobacter Pylori Igg	United Biotech	LYR	Class I	1993-08-10
K922441	Sureseal Bandage	Gainor Medical Europe, Ltd.	KGX	Class I	1993-08-10
K922137	Diascan Blood Glucose Monitoring Test Strip	Home Diagnostics, Inc.	CGA	Class II	1993-08-10
K922136	Ultra+ Blood Glucose Monitoring Test Strip	Home Diagnostics, Inc.	CGA	Class II	1993-08-10
K933298	Saw Blade	Omega Surgical Instruments, Inc.	GFA	Class I	1993-08-09
K933279	Abuscreen Online Benzodiazepines 300 Calibrator	Roche Diagnostic Systems, Inc.	DLJ	Class II	1993-08-09
K932602	Adhesive Bandages	Aso LLC	KGX	Class I	1993-08-09
K932551	Accutex Im Latex Test	J.S. Medical Assoc.	KTN	Class II	1993-08-09
K932466	Medchem Surgical Delivery System	Medco Products, Co., Inc.	GCJ	Class II	1993-08-09
K932459	Fast Set Vinylpolysiloxane Bite Reg. Material	3M Company	ELW	Class II	1993-08-09
K932386	Ventana Red Detection Kit	Ventana Medical Systems Inc	DEY	Class II	1993-08-09
K932265	Symbiosis Dispos Pulmon Biopsy Forceps W/reus Hand	Boston Scientific Corporation	FCL	Class I	1993-08-09
K932127	Tdx/tdxflx & Tdxflx Theophylline Monoclonal II	Abbott Medical	LGS	Class II	1993-08-09
K931525	Sunglasses	Premiums Promotions & Imports, Inc.	HQY	Class I	1993-08-09
K931013	Foley Catheter Tray	Kit Pak, Inc.	KNY	Class II	1993-08-09
K930909	Prizm Hearing System	Audioscience, Inc.	ESD	Class I	1993-08-09
K930699	M6-M	X-Cel X-Ray Corp	IZL	Class II	1993-08-09
K930501	Du Pont Aca Nev/eev Verifier	Dupont Medical Products	JIS	Class II	1993-08-09
K930444	Marco Standard Keratometers	Marco Ophthalmic, Inc.	HJB	Class I	1993-08-09
K930442	Marco Gxx Series Photographic Slit Lamps	Marco Ophthalmic, Inc.	HKI	Class II	1993-08-09
K930438	Marco Models G,h and Primary Care Slit Lamps	Marco Ophthalmic, Inc.	HJO	Class II	1993-08-09
K930437	Marco Standard Radiusgauges	Marco Ophthalmic, Inc.	HLF	Class I	1993-08-09
K925937	Wells Lamont Handages/med Wrap Dressings	Wells Lamont Corp.	KMF	Class I	1993-08-09
K925897	Corin Bipolar Prosthesis	Corin Orthopedic Products	KWY	Class II	1993-08-09
K924370	Staclot(r) Pnp Test Kit	American Bioproducts Co.	GGW	Class II	1993-08-09
K923989	Sensormedics Model 6200 Autobox Dl	Sensor Medics Corp.	BZG	Class II	1993-08-09
K923903	Vitek Immunodiagnostic Assay System Mumps Igg Assa	Biomerieux Vitek, Inc.	LJY	Class I	1993-08-09
K911087	Castle Washer/disinfector, Model 7550	Mdt Biologic Co.			1993-08-09
K930741	Esophageal Intubation Detector	Wolfe-Carney Medical	BTR	Class II	1993-08-07