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 2026-11-02, 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 2483 of 3531

510(k) clearances, page 2483 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K910098	Electone Bte Model Am 240 Ppi	Electone, Inc.	ESD	Class I	1991-01-28
K905827	Full View Omega Table	Med-Tron Products, Inc.	IYX	Class I	1991-01-28
K905733	Seroma-Cath Close Drainage System	Dawn Medical	GCY	Class I	1991-01-28
K905692	143 Series Bte	GN Danavox, Inc.	ESD	Class I	1991-01-28
K905679	133 Series Bte	GN Danavox, Inc.	ESD	Class I	1991-01-28
K905503	Tru-Touch Powder Free	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1991-01-28
K905275	Osteonics(r) Mpss Hip Stem Series	Osteonics Corp.	JDI	Class II	1991-01-28
K905172	Patient Examination Gloves	Tessile, Inc.	LYY	Class I	1991-01-28
K905020	Slidex Strepto-Kit	Vitek Systems, Inc.	GTY	Class I	1991-01-28
K904981	Funky Sunglass	Monogram International,Inc.	HQY	Class I	1991-01-28
K904967	Hospal Bicart Retrofit Kit Na/monit S Gs Hemodial	Gambro-Hosp-Cobe, Inc.	FKP	Class II	1991-01-28
K904917	Thayer Mip Adapter	Thayer Medical Corportation	BXR	Class II	1991-01-28
K904909	I/a Vitrophage Model Ypr 2001	Visioncare Devices, Inc.	HQE	Class II	1991-01-28
K904880	Buechel-Pappas Humeral Stem Component	Endotec, Inc.	KWS	Class II	1991-01-28
K904879	Beuchel-Pappas Glenoid Component	Endotec, Inc.	KWS	Class II	1991-01-28
K904792	Diagnostic Ultrasound Versadopp 1000	Diagnostic Ultrasound Corp.	DPW	Class II	1991-01-28
K904769	Sensitouch	Ansell Intl.	KGO	Class I	1991-01-28
K904597	Grommet Style Venturi	River Medical, Inc.	ETD	Class II	1991-01-28
K904594	Collar Button Style Venturi	River Medical, Inc.	ETD	Class II	1991-01-28
K904592	Bobbin Style Venturi	River Medical, Inc.	ETD	Class II	1991-01-28
K904567	Dynatech Mr4000 Microplate Reader	Dynatech Corp.	JJQ	Class I	1991-01-28
K903854	Rapitex(r) Asl New	Behring Diagnostics, Inc.	GTQ	Class I	1991-01-28
K903504	Hala'tus 1 Oxygenator	The Henry G. Dietz Co., Inc.	NFB	Class II	1991-01-28
K901853	Modified Labeling for Bioclusive* Trans Film Dress	Johnson & Johnson MEDICAL GmbH	NAD	Class I	1991-01-28
K910033	Ubi Magiwel(tm) Ana Quantitative	United Biotech	LJM	Class II	1991-01-25
K905767	Coulter Dart Alt (Gpt) Reagent	Coulter Electronics, Inc.	CKA	Class I	1991-01-25
K905757	Aia-Pack Hgh	Tosoh Medics, Inc.	CFL	Class I	1991-01-25
K905660	Systemate Albumin (Epos Application) #65401	Em Diagnostic Systems, Inc.	CIX	Class II	1991-01-25
K905538	Columns Liquid Chromatography Dpm	Millpore Corp.	KZR	Class I	1991-01-25
K905531	Lupus(le)-Latex Test	Immco Diagnostics, Inc.	LKI	Class I	1991-01-25
K905485	Immunowell Thyroglobulin Test	General Biometrics, Inc.	JZO	Class II	1991-01-25
K905445	Adson-Beckman Retractor, Spinal	A. Henniss	GZT	Class II	1991-01-25
K905255	Neuromed Model 1992 Ls Lamitrode Lead	Neuromed, Inc.	GZB	Class II	1991-01-25
K905151	Vancomycin Disk-5 Mcg	Remel Inc	JTO	Class I	1991-01-25
K905124	Multiple Imaging Xenon Arc Auto Ligh Source	Red Wing Imaging, Inc.	GCT	Class II	1991-01-25
K905111	Digital Disk Recorder(ddr) W/numerical Suffixes	Eigen	JAA	Class II	1991-01-25
K905090	Feel Fresh Toothbrush Kit	Fresh Appeal, Ltd.	EFW	Class I	1991-01-25
K904993	Laparoscopic Electrosurgical Device	Everest Medical Corp.	GEI	Class II	1991-01-25
K904985	Bipolar Biopsy Forceps	Everest Medical Corp.	KGE	Class II	1991-01-25
K904911	Disposable Fiber Optic Delivery System	Fiber Delivery Concepts, Inc.	GEX	Class II	1991-01-25
K904852	Duoderm Dressings, Cgf Dressings, Paste Full Thick	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1991-01-25
K904850	Dual and Single Irr. Systems Models 29550 & 29555	Micro Motors, Inc.	EFS	Class I	1991-01-25
K904603	Quantimetrix Quan Test-Red Protein Assay System	Quantitative Medicine, Inc.	CEK	Class II	1991-01-25
K904393	Premier-Cryptococcal Antigen	Meridian Diagnostics, Inc.	MDU	Class II	1991-01-25
K904325	Coag-1 Pt-Nc Test Card	Cardiovascular Diagnostic Services	GJS	Class II	1991-01-25
K904311	Rheumagen Aso T-Control	Biokit USA, Inc.	GTQ	Class I	1991-01-25
K903531	Anticardiolipin Antibody Test System	Medical Innovations, Inc.	GFO	Class II	1991-01-25
K902450	Bodylog Enhanced Stress Reduction Package	Bodylog, Inc.	HCC	Class II	1991-01-25
K901320	Absorbent, Disposable Urinary Drainage Bag	Ep Medical, Inc.	KNX	Class II	1991-01-25
K901125	Provocative Sensitivity Balloon	Wilson-Cook Medical Inc.	KLA	Class II	1991-01-25