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 2385 of 3531

510(k) clearances, page 2385 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914922	Unisurge Tissue Collection System for Endos Surg	Charles L. Rose and Co., Inc.	GCJ	Class II	1992-03-26
K914317	Orthodontic Bracket Adhesive Resin Material	Confi-Dental Products Co.	DYH	Class II	1992-03-26
K913943	Serim Disintek Reagent Strips	Serim Research Corp.	MED	Class II	1992-03-26
K913898	Myotrac+/s, Myodac+/s	Thought Technology Ltd.	HCC	Class II	1992-03-26
K913658	Imed 4100 and 4200 Disposable Infusion Devices Mod	Imed Corp.	MEB	Class II	1992-03-26
K920243	Smart Burs Total Carbides	Vermont Diamond Instruments	EJL	Class I	1992-03-25
K920021	Lsf Total Hip System - Muller-Type Acetabular Cup	Implant Technology, Inc.	JDI	Class II	1992-03-25
K915666	Amalcoden	Mion International Corp.	EMA	Class II	1992-03-25
K915263	Sunglasses/reading Glasses	Royalking Industrial Corp.	HQY	Class I	1992-03-25
K914604	Mepitel Non-Adherent Silicone Dressing	Molnlycke Clinical Products AB	NAB	Class I	1992-03-25
K914336	Breathe Easy	Vital Signs, Inc.	BYD	Class I	1992-03-25
K912990	Converbase	Wilde-USA, Inc.	EBI	Class II	1992-03-25
K912139	Model 704	Ivy Biomedical Systems, Inc.	GWM	Class II	1992-03-25
K921087	Chemstrip Urine Analyzer	Boehringer Mannheim Corp.	KQO	Class I	1992-03-24
K920716	Direct Pregnancy Test	Tech-Co, Inc.	JHJ	Class II	1992-03-24
K920335	Miles Alanine Aminotransferase Sera-Pak Method	Kulzer GmbH	CKA	Class I	1992-03-24
K920025	Olympus Disposable Suction Valve	Olympus Corp.	EOQ	Class II	1992-03-24
K905273	Bauman Disposable Laryngoscope Blades	Vital Signs, Inc.	CCW	Class I	1992-03-24
K921025	Synermed Ldhh-L Reagent Kit	Synermed, Inc.	CFJ	Class II	1992-03-23
K920914	Mp/s Single Wavelength Mini Photometer	Artel, Inc.	JJQ	Class I	1992-03-23
K920704	Stryker i.v. Caddy Accessory Device	Stryker Medical	FPO	Class II	1992-03-23
K920694	8000 Series Volumetric Pump Non-Gravity Flow Set	Baxter Healthcare Corporation	FPA	Class II	1992-03-23
K920576	Amerlex-M High Sensitivity Unconjugated Estriol	Eastman Kodak Company	CGI	Class I	1992-03-23
K920565	Bbl Strep Grouping Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GTZ	Class I	1992-03-23
K920505	Amerlex-M Extended Range Human Chorionic Gonadatr	Eastman Kodak Company	JHI	Class II	1992-03-23
K920473	Cefprozil 30Mcg, Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1992-03-23
K920350	Chem-Chem Multi-Analyte (Modified)	Streck Laboratories, Inc.	JJY	Class I	1992-03-23
K920167	Nextec Fiberoptic Illuminat 150 Watt/halo/3500 Kel	Nextec Corp.	HBI	Class II	1992-03-23
K915870	Opus Rubella Test System	Pb Diagnostics, Inc.	LFX	Class II	1992-03-23
K915868	Perfecta Total Hip System, Hemi-Head Component	Orthomet, Inc.	KWL	Class II	1992-03-23
K915840	Zeiss Multiyag Laser	Carl Zeiss, Inc.	GEX	Class II	1992-03-23
K915835	Coated Vicryl* II	Ethicon, Inc	GAM	Class II	1992-03-23
K915521	Tracker(r) Unibody Cath & Tracker 25 Cath,modified	Target Therapeutics	DQY	Class II	1992-03-23
K915330	Directigen Meningitis Combo Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GTJ	Class II	1992-03-23
K915281	Serolisa Chlamydia Igg Test Kit	Savyon Diagnostics Ltd.	LJC	Class I	1992-03-23
K914690	Lm15(tm), Catalog Number - 523821	Edward Weck, Inc.	GCJ	Class II	1992-03-23
K912242	Prospect(tm/cryptosporidium	Alexon, Inc.	MHJ	Class II	1992-03-23
K911663	Crosslink System	Synthes (USA) Products LLC	KWP	Class II	1992-03-23
K921027	Manual Chair Base	Labac Systems, Inc.	KNN	Class I	1992-03-20
K920784	Orthodontic Face Bow W/ Inner Wire	Gac Intl., Inc.	DZB	Class II	1992-03-20
K920581	Polar Pad (Sterile)	Breg, Inc.	ILO	Class II	1992-03-20
K920557	Wil-O-Dont Orthodontic Material/wil-O-Lux	Wilde-USA, Inc.	EBI	Class II	1992-03-20
K920425	3M Brand Restorative Z100	3M Company	EBF	Class II	1992-03-20
K920424	Scotchbond Brand Multi-Purpose Adhesive System	3M Company	KLE	Class II	1992-03-20
K920309	Sienet Diagnostic Reporting Console	Siemens Gammasonics, Inc.	LLZ	Class II	1992-03-20
K915804	Propper Laryngoscope Blades W Fiber Optic Illum.	Propper Mfg Co Inc	CCW	Class I	1992-03-20
K915538	Over the Wire Stone Basket	Medical Dynamics, Inc.	LQR	Class II	1992-03-20
K915277	Endotracheal CPAP Set	Vital Signs, Inc.	BTR	Class II	1992-03-20
K914905	Entrac(tm) Urethral Measuring Catheter	American Medical Systems, Inc.	GBM	Class II	1992-03-20
K914318	Glass Ionomer Cement	Confi-Dental Products Co.	EMA	Class II	1992-03-20