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 2176 of 3531

510(k) clearances, page 2176 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942549	Alko Fluids Packs for Nova 8 Analyzers	Alko Diagnostic Corp.	JIX	Class II	1994-07-28
K942404	Cedia(r) Dau Barbiturate Assay, Modification	Microgenics Corporation	DIS	Class II	1994-07-28
K942280	Goretex Sam Facial Implant	W. L. Gore & Associates, Inc.	FWP	Class II	1994-07-28
K942214	H55 Hydrophilic Contact Lens	Martin S. Knopf Assoc., Inc.	LPL	Class II	1994-07-28
K942187	Esstech Sv(polymacon) Soft (Hydrophilic) Contact Lens	Szabocsik and Assoc.	LPL	Class II	1994-07-28
K942186	Esstech Ps Aspheric	Szabocsik and Assoc.	LPL	Class II	1994-07-28
K942057	Fisher-Price Dry Night Monitor	Fisher Price	KPN	Class II	1994-07-28
K941876	Whole Blood Volatiles Control, Levels 1 and 2	More Diagnostics Inc.	JJY	Class I	1994-07-28
K941698	Serum Volatiles Control - Levels 1 and 2	More Diagnostics Inc.	JJY	Class I	1994-07-28
K941408	Merit	Philips North America LLC	LNH	Class II	1994-07-28
K941176	Alginate Fiber	Adri/Technam	KMF	Class I	1994-07-28
K940557	Staphytect-Od	Unipath, Ltd.	LHJ	Class I	1994-07-28
K940507	Opus Ft4 Test System	Pb Diagnostic Systems, Inc.	CEC	Class II	1994-07-28
K940362	Ana Screen Elisa Test System	Zeus Scientific LLC	LLL	Class II	1994-07-28
K940169	Debusk Temperature Systems Premier and Signature Series Multi-Purpose Esophageal Stethoscope	DeRoyal Industries, Inc.	BZT	Class II	1994-07-28
K935127	Southland Sterile Dental System	Southland, Ltd.	EKJ	Class I	1994-07-28
K935017	Td50 Electromyograph	Medelec Intl. Corp.	JXE	Class II	1994-07-28
K934728	Sunsor Ultraviolet Meter	Sunsor, Inc.	EAQ	Class II	1994-07-28
K933367	Gore-Tex Facial Implant	W. L. Gore & Associates, Inc.	FWP	Class II	1994-07-28
K933153	Penthouse Condoms	Kuron Health Products Corp.	HIS	Class II	1994-07-28
K932789	One-Site IV Connector	Care Medical Devices, Inc.	FOZ	Class II	1994-07-28
K930773	Symbiosis Gynecological Biopsy Forceps	Boston Scientific Corporation	HFB	Class I	1994-07-28
K915236	Iris G-Probe	Iriderm Div.	GEX	Class II	1994-07-28
K943461	Various Types of Mercurials	Rud Riester GmbH & CO KG	DXN	Class II	1994-07-27
K943457	As/3 Pressure Temperature Module, M-Pt	Datex Division Instrumentarium Corp.	DSK	Class II	1994-07-27
K943234	Ms-30 Automatic Perimeter	Marco Ophthalmic, Inc.	HPT	Class I	1994-07-27
K943202	Eassun Hi-Tech Optics	Ultimate Concepts, Inc.	HQY	Class I	1994-07-27
K943116	Auto Suture Kerrison Spinal Rongeur	United States Surgical, A Division of Tyco Healthc	HAE	Class II	1994-07-27
K942932	Gladiator	Gladiator Sports	HQY	Class I	1994-07-27
K942839	Olympus Superview Laparoscope for General Surgery	OLYMPUS Corporation of the Americas	GCJ	Class II	1994-07-27
K942777	Minimus II; Minimus II Color; Babyphon	Rudolf Riester GmbH & Co. KG	DXQ	Class II	1994-07-27
K942645	B&f Medical Oxygen Reg Mecical Oxy Compress Gas Reg	B & F Medical Products, Inc.	BXH	Class I	1994-07-27
K941839	Disposable Surgical Cable	Conmed Andover Medical, Inc.	DSA	Class II	1994-07-27
K941233	Global Shoulder o.r. Drape Pack	Depuy, Inc.	KKX	Class II	1994-07-27
K941044	Playtex Ultimated Tampons Model Number 06194	Playtex, Inc.	HIL	Class II	1994-07-27
K940168	Diagnostic II Catheter	Ep Technologies, Inc.	DRF	Class II	1994-07-27
K940041	Colibri	Icor AB	BTR	Class II	1994-07-27
K934941	E-Z Temp II	Seven C'S, Inc.	KPD	Class II	1994-07-27
K934600	Microdrive	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1994-07-27
K932293	Cabot Medical Bipolar Cutting Forceps	Cabot Medical Corp.	KNS	Class II	1994-07-27
K931335	Scimed(r) Venture(tm) Infusion Catheter	Scimed Life Systems, Inc.	KRA	Class II	1994-07-27
K926564	Optical Frames and Sunglasses	Solstar Produktions GmbH	HQY	Class I	1994-07-27
K925243	Deknatel(tm) Pleur-Evac(r) Thoracic Catheter	Deknatel, Inc.	GBX	Class I	1994-07-27
K943231	Bioplar Forceps	Cook Incorporated	GEI	Class II	1994-07-26
K943073	Curafil Wound Gel Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	MGQ	Unclassified	1994-07-26
K942950	Body Flex	Conair LLC.	ISA	Class I	1994-07-26
K942577	Surgical Tip Cleaner	White Knight Healthcare	GEI	Class II	1994-07-26
K942275	Vial Vent Filter	Gelman Sciences, Inc.	FPB	Class II	1994-07-26
K942103	L-Cath Catheter System - Port L-Cath	Luther Medical Products, Inc.	LJT	Class II	1994-07-26
K942024	Port-a-Cath Low Profile Implantable Venous Access System	Pharmacia Deltec, Inc.	LJT	Class II	1994-07-26