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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 748 of 3530

510(k) clearances, page 748 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142281	Zimmer M/dn Intramedullary Fixation System	Zimmer GmbH	HSB	Class II	2014-10-22
K141908	Dual Switch	Laser Engineering, Inc.	GEX	Class II	2014-10-22
K141724	Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	Liaoning Upcera Co.,Ltd	EIH	Class II	2014-10-22
K141723	Upcera Coloring Liquid (I and II )	Liaoning Upcera Co.,Ltd	EIH	Class II	2014-10-22
K141658	Light Scalpel	Lightscalpel Inc	GEX	Class II	2014-10-22
K141603	Ultra Silver Dressings	Milliken Healthcare Products, LLC	FRO	Unclassified	2014-10-22
K141544	Zimmer Zfx Titanium Abutment for Biomet 3I Certain Implant System	ZimVie US Corp LLC	NHA	Class II	2014-10-22
K141491	Solitaire 2 Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	NRY	Class II	2014-10-22
K141211	Inclusive Titanium Abutments Compatible with Straumann Tissue Level Implants	Prismatik Dentalcraft, Inc.	NHA	Class II	2014-10-22
K140251	Universal Digital Interface 2, UDI 2	Meridian Medical Systems, LLC	MQB	Class II	2014-10-22
K133849	Vantera Clinical Analyzer	Liposcience	NSU	Class II	2014-10-22
K142381	Xia 3 Spinal System	Stryker Corp.	NKB	Class II	2014-10-21
K142042	Erchonia Shl	Erchonia Corporation	OLI	Class II	2014-10-21
K142003	Fdr D-Evo II Flat Panel Detector System	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2014-10-21
K141904	Viora V-Touch	Viora, Ltd.	GEI	Class II	2014-10-21
K141820	Jagwire High Performance Guidwire	Boston Scientific Corporation	OCY	Class II	2014-10-21
K141651	Sensititre Susceptibility Plates	Thermo Fisher Scientific Oy	JWY	Class II	2014-10-21
K141604	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2014-10-21
K140197	Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System	Teleflexmedical, Inc.	CAC	Class II	2014-10-21
K142026	Spinefrontier Arena-C Ha Peek Cervical Intervertebral Body Fusion Device	SPINEFRONTIER, Inc. dba LESspine Innovations	ODP	Class II	2014-10-20
K140993	Ionostar Molar	Voco GmbH	EMA	Class II	2014-10-20
K140268	Simple T Youth Nasal Mask	Respironics, Inc.	BZD	Class II	2014-10-20
K140236	Aileron Interspinous Fixation System	Life Spine	PEK	Class II	2014-10-20
K132490	Skore and Multiple Brands	Ttk Protective Devices Limited (Formerly Ttk-Lig L	HIS	Class II	2014-10-20
K142660	Antegrade LeMills Valvulotome	LeMaitre Vascular Inc.	MGZ	Class II	2014-10-17
K142636	Merit 10mL Syringe	Merit Medical Systems, Inc.	FMF	Class II	2014-10-17
K142589	Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL	Titan Spine, LLC	MAX	Class II	2014-10-17
K142267	Sherlock 3CG Tip Positioning System Stylet	C.R. Bard Inc	LJS	Class II	2014-10-17
K142252	XprESS Multi-Sinus Dilation Tool	Entellus Medical, Inc.	LRC	Class I	2014-10-17
K142220	Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)	Nova Biomedical Corporation	CHL	Class II	2014-10-17
K142096	T-Piece Resuscitator	Mercury Medical	BTL	Class II	2014-10-17
K142091	Parietene Macroporous Mesh	Sofradim Production	FTL	Class II	2014-10-17
K141917	Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear	Unicon Optical Co., Ltd.	LPL	Class II	2014-10-17
K141742	Ardo Carum and Calypso Powered Breast Pumps	Ardo Medical AG	HGX	Class II	2014-10-17
K141600	Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded Kit	Pioneer Surgical Technology, Inc. (Rti Surgical, I	MQV	Class II	2014-10-17
K141579	EMG Black Nitrile Medical Examination Glove Powder Free	Eco Medi Glove Sdn Bhd	LZA	Class I	2014-10-17
K141426	Elecsys Folate III	Roche Diagnostics GmbH	CGN	Class II	2014-10-17
K141344	Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System	Boston Scientific Corporation	FAD	Class II	2014-10-17
K141335	Expel Apd Drainage Catheter System	Boston Scientific Corporation	FGE	Class II	2014-10-17
K141242	Glide Device	Home Skinovations, Ltd.	OHT	Class II	2014-10-17
K141165	Matrixwave Mmf System	Synthes (USA) Products LLC	JEY	Class II	2014-10-17
K141152	Advantage	Stevenson Industries, Inc.	BZD	Class II	2014-10-17
K140929	Z1 CPAP System	Breas Medical AB	BZD	Class II	2014-10-17
K140783	Halo Ambulatory Infusion System	Zyno Medical LLC.	FRN	Class II	2014-10-17
K140728	Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and Pr	Ditron Precision, Ltd.	DZE	Class II	2014-10-17
K140581	Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port	Cedic S.r.l.	PIO	Class II	2014-10-17
K140472	Bonastent Tracheal / Bronchial	Boston Scientific Corporation	JCT	Class II	2014-10-17
K133360	Aeroneb Solo; Aeroneb Solo Adapter	Aerogen Ltd.	CAF	Class II	2014-10-17
K142653	G-Lok and G-Lok XL Extender	T.A.G. Medical Products Corporation Ltd	MBI	Class II	2014-10-16
K142618	Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System	Hitachi Aloka Medical America, Inc.	ITX	Class II	2014-10-16