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 2409 of 3531

510(k) clearances, page 2409 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K912642	Ems300, Ems400, Ems8000	Skylark Device Co., Ltd.	IPF	Class II	1991-12-09
K912342	Dr. Liberson's Micropulse Neuromuscular Trans Stim	Amer Inst of Electrodiagnosis/Electrotherapy, Inc.	IPF	Class II	1991-12-09
K912099	3M Fluid Control System Small Joint Cops Cannula	3M Company	HRX	Class II	1991-12-09
K912040	Latex Examination Gloves	Pt. Indoraya Everlatex	LYY	Class I	1991-12-09
K911661	Anti-Cardiolipin Antibody Test System	IMMUNO CONCEPTS, NA, Ltd.	MID	Class II	1991-12-09
K910983	IV 1000 Insufflator Rapid Flow	M.D. Engineering, Inc.	HIF	Class II	1991-12-09
K904391	Vident Impac Implant Accessories	Vident	DZE	Class II	1991-12-09
K914089	Sharplan Sharplase Family of Handswitched Nd:yag	Sharplan Lasers, Inc.	GEX	Class II	1991-12-06
K914058	Nk Pinch Sensor, Model Pa002	Nk Biotechnical Engineering Co.	LBB	Class II	1991-12-06
K914009	Schneider Softip(r) A+(tm) Angiographic Catheter	Schneider Intl., Ltd.	DQO	Class II	1991-12-06
K915252	Philips P74p Behind-the-Ear Hearing Aid	Philips Hearing Instruments Co.	ESD	Class I	1991-12-05
K914762	Micro Med Inc. Qrs-Card(tm) Office ECG Monitor	MicroMed, LLC	DPS	Class II	1991-12-05
K914503	Grasping Forceps	Surgitek Medical Engineering Corp.	OCZ	Class II	1991-12-05
K914496	Sclerotherapy Needle	Surgitek Medical Engineering Corp.	FBK	Class II	1991-12-05
K914237	Kinamed Ctn Stem	Kinamed Inc	LZO	Class II	1991-12-05
K914016	Zara Zone IV Malar Implant	Byron Medical	LZK	Class II	1991-12-05
K914004	Alphatec Cannulated Bone Screws	Alphatec Spine, Inc.	HWC	Class II	1991-12-05
K913356	The Monitor/demlar Model Mi-5000 Audiometer	Monitor Instruments, Inc.	EWO	Class II	1991-12-05
K912293	Remove Labeling Restrict from Guide Wires	Target Therapeutics	DQX	Class II	1991-12-05
K912088	Biopsy Accessories for Ultrasound Probes	Biosound, Inc.	ITX	Class II	1991-12-05
K912049	System Athena - Product Enhancements	S & W Medico Teknik	DRT	Class II	1991-12-05
K914971	Tec-8251A Defibrillator Monitor, Modification	Nihon Kohden America Inc	LDD	Class II	1991-12-04
K914937	Sterile Bandage, Gauze, Fine Mesh, 3X8 Inches	Kerma Medical Products, Inc.	NAB	Class I	1991-12-04
K914912	Promeon 63B Surgical Tape	Promeon	KGX	Class I	1991-12-04
K914873	Diazo Colorimetry, Bilirubin	Horiba Instruments Incorporated	CIG	Class II	1991-12-04
K914842	Gauze Bandage Roll	Cal West Trading Co.	NAB	Class I	1991-12-04
K914810	Easylyte Sodium/potassium/lithium Analyzer	Medica Corp.	JGS	Class II	1991-12-04
K914779	Alginate Fiber	Adri/Technam	NAC	Class I	1991-12-04
K914742	Myocard Protect Syst W/blood Cardio Heat Exc/modif	Medtronic, Inc.	DTR	Class II	1991-12-04
K914575	Sorbsan Topical Wound Dressing (Modified)	Dow B. Hickam, Inc.	NAC	Class I	1991-12-04
K914549	Ethicon Absorbable Suture Clip and Applier	Ethicon, Inc	GCJ	Class II	1991-12-04
K914449	Gore-Tex(r) Soft Tissue Patch, Process Change	W. L. Gore & Associates, Inc.	FTL	Class II	1991-12-04
K914431	Absorbent Fiber	Ulti-Med Intl., Inc.	NAB	Class I	1991-12-04
K914114	2Dtof Magnetic Resonance Angiograph (Mra)	Resonex, Inc.	LNH	Class II	1991-12-04
K914071	Multiple Burn Dressing	Kerma Medical Products, Inc.	NAB	Class I	1991-12-04
K914024	Viaderm	Abs Life Sciences	KGN	Unclassified	1991-12-04
K914014	Facstrak Flow Cytometer	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1991-12-04
K914000	Global(tm) Total Shoulder W/dupont Enhanced Uhmwpe	Depuy, Inc.	KWT	Class II	1991-12-04
K913965	Espe(r) -Sil	Espe GmbH (US)	KLE	Class II	1991-12-04
K913961	Ophthalmic Stand	Luneau Ophtalmologie SA	HMF	Class I	1991-12-04
K913779	Bandage Roll, Gauze	Keilei Intl., Inc.	NAB	Class I	1991-12-04
K913520	Evacu Sled	Nexus Health Care Products, Ltd.	FPP	Class I	1991-12-04
K913273	Drolite(tm) Light Source	Vision Medical Inc	HJM	Class II	1991-12-04
K913249	Acs Ultra-1 Thromboplastin	Analytical Control Systems	GJS	Class II	1991-12-04
K913185	Sterile Stainless Steel Monofil Nonabsorb Surg Sut	Internacional Farmaceutica, S.A. de C.V.	GAQ	Class II	1991-12-04
K912869	Women and Infant's Delivery Pack	Welcon, Inc.	HFW	Class II	1991-12-04
K912660	Securodrip	Op-Co Medical Products, Ltd.	KMK	Class I	1991-12-04
K912620	Opomat Manual Resuscitator Ventilator	Euro-Am Pharma, Inc.	BTM	Class II	1991-12-04
K912592	Cmv-Ea Mab Test	Gull Laboratories, Inc.	LIN	Class II	1991-12-04
K912188	Dinamap Plus Physiological Monitor Model 8700	Critikon Company, LLC	MHX	Class II	1991-12-04