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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3371 of 3526

510(k) clearances, page 3371 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792620	Neonatal Heated Humidifier	Modern Medical Systems Co.	BTT	Class II	1980-01-24
K792466	Nic-200 Ventricular Function Analyzer	Nicolet Biomedical Instruments	DQC	Class I	1980-01-24
K800090	Fluoromatic Phenolbarbital Fia	Bio-Rad	DKP	Class II	1980-01-23
K800060	Provit	Parker Laboratories, Inc.	EMA	Class II	1980-01-23
K800053	Kodak Ektachem Four Chemistry Analyzer	Eastman Kodak Company	JJE	Class I	1980-01-23
K800049	Delta Test Amylase UV	BD Becton Dickinson Vacutainer Systems Preanalytic	JFJ	Class II	1980-01-23
K800045	Quantimune Cortisol Ria Cortisol Radio-	Bio-Rad	CGR	Class II	1980-01-23
K800032	Fiax Test Kit for Gentamicin Quan.	Intl. Diagnostic Technology	LCQ	Class II	1980-01-23
K792720	Tryptic Soy Sxt Agar W/sheep Blood	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1980-01-23
K792713	Candida Albicans, Antiserum	Meridian Diagnostics, Inc.	GMI	Class II	1980-01-23
K792701	Histoplasma Capsulatum, Antigen	Meridian Diagnostics, Inc.	GMJ	Class II	1980-01-23
K792683	Blastomyces/antigen for Immunodifusion	Meridian Diagnostics, Inc.	JWW	Class II	1980-01-23
K792644	Telesonic V-101	Telesonic, Inc.	ESD	Class I	1980-01-23
K792643	Hearing Aid, Models Dri-35/Dl1-35	Unitron Industries, Inc.	ESD	Class I	1980-01-23
K792567	Widex Hearing Aid Model 820	Widex Hearing Aid Co., Inc.	ESD	Class I	1980-01-23
K792469	Intersci Test for Alcohol in Body Fluids	Intersci Corp.	DOJ	Class II	1980-01-23
K792430	Cardiassist External Counterpulsation	Cardiassist Corp.	DRN	Class II	1980-01-23
K792428	Coe-Sil	Coe Laboratories, Inc.	LDG	Class I	1980-01-23
K792389	Widex Hearing Aid Model S10	Widex Hearing Aid Co., Inc.	ESD	Class I	1980-01-23
K792329	Biophase Implant Material	Richard'S Medical Equip., Inc.	JDG	Class II	1980-01-23
K792250	Cutter Points	Cutter Laboratories, Inc.	EHL	Class I	1980-01-23
K792249	Fiax Test Kit for Anti-Rubella Antibod	Intl. Diagnostic Technology	GOL	Class II	1980-01-23
K800047	Ldc Uviii Fixed Wavelength Ultraviolet	Laboratory Data Control	KIE	Class I	1980-01-21
K800043	Cesium Diluent (1.5 Mm/l)	Gilford Diagnostics	JIX	Class II	1980-01-21
K800042	Lithium Standard (1Mm/l)	Gilford Diagnostics	JIS	Class II	1980-01-21
K800041	Sodium/potassium 140/5 Meq/l)	Gilford Diagnostics	JIX	Class II	1980-01-21
K800040	Sodium/potassium (100/100 Meq/e)	Gilford Diagnostics	JIX	Class II	1980-01-21
K800039	Lithium Diluent (1500 Mm/e)	Gilford Diagnostics	JIH	Class II	1980-01-21
K800038	Alt Reagent	Gilford Diagnostics	CKA	Class I	1980-01-21
K800036	Total Estriol Ria Kit	Amersham Corp.	CGI	Class I	1980-01-21
K800035	Pentex Lipoprotein Cholesterol Solu.	Miles Laboratories, Inc.	JJX	Class I	1980-01-21
K800028	Worthington Flozyme* Cpk (340Nm)	Worthington Diagnostic Systems	JHS	Class II	1980-01-21
K800019	Bk-1544 Be Ok Scoop Disk	Fred Sammons, Inc.	ILC	Class I	1980-01-21
K800018	Bk-5203 Facilitation Vibrator Electric	Fred Sammons, Inc.	IRO	Class I	1980-01-21
K800017	Color Coded Putty Soft, Regular & Firm	Fred Sammons, Inc.	ION	Class I	1980-01-21
K800016	Dupont Aca Ion Selective Electrode	E.I. Dupont de Nemours & Co., Inc.	CEM	Class II	1980-01-21
K800007	Work Simulator	Baltimore Therapeutic Equipment Co.	BXB	Class I	1980-01-21
K792723	Blood Fluid Filters	Dade, Baxter Travenol Diagnostics, Inc.	JKA	Class II	1980-01-21
K792707	Para-Pak Saf	Meridian Diagnostics, Inc.	IGG	Class I	1980-01-21
K792705	Para-Pak Formalin	Meridian Diagnostics, Inc.	IGG	Class I	1980-01-21
K792693	Cryptococcus Neoformans Antiserum, Latex	Meridian Diagnostics, Inc.	GMD	Class II	1980-01-21
K792585	Smv 120 Sonic Mammographic Viewer	Johnson & Johnson Professionals, Inc.	IYO	Class II	1980-01-21
K792574	Mopso Buffer	Electrophoresis Corp. of America	JCC	Class I	1980-01-21
K792325	Liverpool Knee Prosthesis	Downs Surgical, Ltd.	HRY	Class II	1980-01-21
K792233	Centria Fsh Ria	Union Carbide Corp.	CGJ	Class I	1980-01-21
K800021	Non Adherant Neurological Sponges	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-17
K800020	Non Adherant Wound Bandages	American Medical Disposable, Inc.	EFQ	Unclassified	1980-01-17
K800014	Dow Corning/w Right Wound Drainage Sys	Dow Corning Corp. Healthcare Industries Materials	GCY	Class I	1980-01-17
K792718	Histoplasma Capsulatum, Antiserum	Meridian Diagnostics, Inc.	GMK	Class II	1980-01-17
K792717	Coccidioides Immitis, Antiserum Pos.	Meridian Diagnostics, Inc.	GMH	Class II	1980-01-17