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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2929 of 3529

510(k) clearances, page 2929 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854399	Model 20-B CO2 Laser System	Directed Energy, Inc.	GEX	Class II	1986-02-07
K854398	Model CO2 Laser System 8B	Directed Energy, Inc.	GEX	Class II	1986-02-07
K854387	Model 8A Previously Mini Halo CO2 Laser System	Directed Energy, Inc.	GEX	Class II	1986-02-07
K854134	Fiberoptic Collimating Handpiece	Dawn Laser Technology, Inc.	GEX	Class II	1986-02-07
K854122	Precious Lite Model 4224	E & B Technologies, Inc.	LBI	Class II	1986-02-07
K853727	Kestrel Contact Lens Storage Case(polysulfone)	Ryder Intl. Corp.	LRX	Class II	1986-02-07
K853627	Codman Laser Rods	Cerenovus, Inc.	GEX	Class II	1986-02-07
K853626	Codman Laser Backstop	Cerenovus, Inc.	GEX	Class II	1986-02-07
K853432	5.0 Iop & 7.5 Iop Probes	Diasonics, Inc.	GXW	Class II	1986-02-07
K853420	Cartovar Brain Mapping Electrodiagnostics	Alvar	OLT	Class II	1986-02-07
K852950	Visitherm	C.D. Regelin & Associates, Inc.	IYM	Class III	1986-02-07
K834162	Vit Pac	American Surgical Company, LLC	HQE	Class II	1986-02-07
K834160	Vitreonic Plus	American Surgical Company, LLC	HQE	Class II	1986-02-07
K860301	Rapid Glutamic Acid Decarboxylase (Gdc) Microtube	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1986-02-06
K860227	Powered Traction Equipment	R. P. Hood, Inc.	ITH	Class II	1986-02-06
K860159	Thumper (Vibrator/massager)	Wellness Innovations Corp.	IRO	Class I	1986-02-06
K860154	Bun (Enzymatic Berthelot) Reagent Set	Sterling Diagnostics, Inc.	CDL	Class II	1986-02-06
K860140	Stratus N-Ace (Napa) Fluorometric Enzyme/immuno.	American Dade	LAN	Class II	1986-02-06
K860134	Easy-Test Alkaline Phosphatase (Alp) Reagent	Em Diagnostic Systems, Inc.	CJE	Class II	1986-02-06
K860109	Enzymatic Urea Nitrogen Reagent Set	Technostics Intl.	CDQ	Class II	1986-02-06
K860052	Qwik-Call	Emde Corp.	KNT	Class II	1986-02-06
K860029	Ldh (Optimized) Reagent	Sigma Chemical Co.	CFJ	Class II	1986-02-06
K855169	T3 Uptake Radioimmunoassay Kit	Cambridge Medical Technology	KHQ	Class II	1986-02-06
K855052	Table Radiographic Fixed	X-Ray Systems	IXQ	Class II	1986-02-06
K854971	V-Trend Eia T4 Enzyme Immunoassay Test Kit	V-Tech, Inc.	KLI	Class II	1986-02-06
K854936	Eia Processor	Abbott Medical	JJE	Class I	1986-02-06
K854730	Daisy (Absorbent Incontinence Shield)	Lic-Orthion	EYQ	Class I	1986-02-06
K854729	Adam (Absorbent Incontinence Shield)	Lic-Orthion	EYQ	Class I	1986-02-06
K854354	The Bledsoe Passive Motion Exerciser	Medical Technology and Innovations, Inc.	BXB	Class I	1986-02-06
K854222	Diesse RF Test Kit	Marvic Interpharma, Inc.	DHR	Class II	1986-02-06
K853979	Cardimax Fx-1164	Brentwood Instruments, Inc.	DPS	Class II	1986-02-06
K852609	Mevassist(setup Controller)	Magus Microcontrollers, Inc.	IYE	Class II	1986-02-06
K860302	Pyr Discs	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1986-02-05
K860293	Cellmatic Chlamydia Culture Confirm-Mccoy Cells	Difco Laboratories, Inc.	KIR	Class I	1986-02-05
K860292	Cellmatic Chlamydia Culture Confirm-Difco-1000	Difco Laboratories, Inc.	KIR	Class I	1986-02-05
K860282	Rpmi 1640 W/glutamine W/hepes	Newport Biosystems, Inc.	KIT	Class I	1986-02-05
K860241	Jms Av Fistula Needle	JMS Co., Ltd.	FIE	Class II	1986-02-05
K860230	Capd Transfer Set Spike 5C4363	Travenol Laboratories, S.A.	KDJ	Class II	1986-02-05
K860152	Model 700 Evacuator for Use with Laser Surgery	Endo Lase, Inc.	LNK	Class II	1986-02-05
K860063	Nd:yag Laser Single Use Fiber Delivery System	Laser Media	LNK	Class II	1986-02-05
K860060	Rx02 Plus Oxygen Concentrator	The John Bunn Co.	CAW	Class II	1986-02-05
K860056	Berkowits 2200 Short Wave (Thermolysis Epilator)	Berkowits School of Electrolysis	KCW	Class I	1986-02-05
K855205	Mycotrim Tm Vl Triphasic Culture System	Hana Biologics, Inc.	JSI	Class I	1986-02-05
K855144	Touriquet Kit with Snare	Dlp, Inc.	GDJ	Class I	1986-02-05
K855068	Spirometer, Model Ts-500 Part #Slz7534	Teledyne Avionics Div. of Teledyne	BTY	Class II	1986-02-05
K854666	Cytomegalovirus (Cmv) Elisa Test Sys. Cat. No:4530	Clinical Sciences, Inc.	GQI	Class II	1986-02-05
K854577	Precept Amoxicillin/clavvlanic Acid (Augmentin)	Austin Biological Laboratories	JWY	Class II	1986-02-05
K854569	Hemor-Ice	Technology 2000	LKX	Unclassified	1986-02-05
K853484	Indirect Enzyme Linked Immunosorbent Assay Igg Ant	Biotech Research Laboratories, Inc.	GNP	Class I	1986-02-05
K853434	Ergo-Pneumotest	Erich Jaeger, Inc.	BZL	Class II	1986-02-05