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 774 of 3530

510(k) clearances, page 774 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132681	Sol-Guard Insulin and Tuberculin Safety Syringe	Sol-Millennium Medical, Inc.	MEG	Class II	2014-05-22
K131892	Ev1000 Clinical Platform	Edwards Lifesciences LLC	DXG	Class II	2014-05-22
K131588	Vigileo Arterial Pressure Cardiac Output/oximetry Monitor; Vigileo Apco/oximetry Monitor	Edwards Lifesciences LLC	DXG	Class II	2014-05-22
K123876	Synergy	Odontit SA	NPM	Class II	2014-05-22
K140611	Trinica Anterior Lumbar Plate System	Zimmer Spine, Inc.	KWQ	Class II	2014-05-21
K140533	Galaflex Mesh	Tepha, Inc.	OOD	Class II	2014-05-21
K140340	Skintact	Leonhard Lang GmbH	GXY	Class II	2014-05-21
K140169	Vital-Port(r) CT Vascular Access System	Cook Incorporated	LJT	Class II	2014-05-21
K140151	Ekosonic Mach 4 Endovascular Device/ekosonic Control Unit	Btg International, Inc.	QEY	Class II	2014-05-21
K140094	Springtms Total Migraine System	Eneura Therapeutics	OKP	Class II	2014-05-21
K140074	Hygedent Alginate Impression Material	Hygedent Inc.	ELW	Class II	2014-05-21
K134043	No Touch+forehead Ntf 3000 Thermometer	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	FLL	Class II	2014-05-21
K133738	Novofine Plus 32G 4 Mm	Novo Nordisk a/S	FMI	Class II	2014-05-21
K133598	Cardiohelp System	MAQUET CARDIOPULMONARY GmbH	DTQ	Class II	2014-05-21
K133482	Silc Fixation System	Globus Medical, Inc.	OWI	Class II	2014-05-21
K133428	Medikro Nano, Medikro Primo and Medikro Pro	Medikro Oy	BZG	Class II	2014-05-21
K132937	Harvest Dental Polymer Blocks (Zcad, Aurora)	Harvest Dental Products LLC	EBG	Class II	2014-05-21
K132802	Motex Powdered Nitrile Surgical Gloves	Shanghai Motex Healthcare Co., Ltd.	KGO	Class I	2014-05-21
K132470	Solum IV Bone Void Filler	Spinesmith Partners, LLP	MQV	Class II	2014-05-21
K131609	Double Engine Intrameddullary Nail System	Xiamen Double Engine Medical Material Co., Ltd.	HSB	Class II	2014-05-21
K141023	Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2014-05-20
K140948	Romeo Posterior Osteosynthesis System	Spineart SA	MNH	Class II	2014-05-20
K140925	Acumed Suture Anchor System	Acumed LLC	MBI	Class II	2014-05-20
K140835	General and Plastic Surgery	Scion Medical Technologies, LLC	NEU	Class II	2014-05-20
K140576	Y Wire 2	Safewire, LLC	HXI	Class I	2014-05-20
K140483	Asap OTC Wound Dressing Gel	ABL Medical, LLC	FRO	Unclassified	2014-05-20
K140448	Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay	Becton Dickinson & Co	LSL	Class II	2014-05-20
K140447	Bd Viper Lt System	Becton Dickinson & Co	OOI	Class II	2014-05-20
K140446	Bd Probetec Chlamydia Trachomatis (CT) Qx Amplified DNA Assay	Becton Dickinson & Co	MKZ	Class I	2014-05-20
K140165	Mc2 Two-Stage Venous Cannula, Oval Mc2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, Mc2x Three-Stage Ve	Medtronic, Inc.	DWF	Class II	2014-05-20
K140095	Prime Zoom Stretcher	Stryker Corp.	INK	Class II	2014-05-20
K133082	Osteosymbionics Patient-Specific Cranial Plate	Osteosymbionics, LLC	GXN	Class II	2014-05-20
K132377	Osteospan Morpheus	Biogennix, LLC	MQV	Class II	2014-05-20
K132291	Namsa Chemical Process	North American Science Assoc., Inc.	JOJ	Class II	2014-05-20
K141043	Cs2 Multi-Hole Acetabular Shell	Consensus Orthopedics, Inc.	LPH	Class II	2014-05-19
K141015	Intellivue Patient Monitor Mx400, Intellivue Patient Monitor Mx450, Intellivue Patient Monitor Mx500, Intellivue Patient	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2014-05-19
K140526	Nxstage System One	NxStage Medical Inc	KDI	Class II	2014-05-19
K133853	Viewflex Xtra Ice Catheter	Irvine Biomedical. Inc.	OBJ	Class II	2014-05-19
K133793	Persyst 12 ( P12) Egg Review and Analysis Software	Persyst Development LLC	OMB	Class II	2014-05-19
K133014	Dms 300-2W Holter ECG Recorder	Diagnostic Monitoring Software	MWJ	Class II	2014-05-19
K132703	Thunderbeat	Olympus Medical Systems Corp.	GEI	Class II	2014-05-19
K132108	Maxio	Perfint Healthcare Pvt, Ltd.	JAK	Class II	2014-05-19
K122556	Vision Biosystems Estrogen Receptor Clone 6F11 (Er 6F11)	Leica Biosystems Newcastle Ltd.	MYA	Class II	2014-05-19
K141041	Aptus Heli-Fx Ancillary Endoanchor Cassette	Aptus Endosystems, Inc.	OTD	Class II	2014-05-16
K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	JWH	Class II	2014-05-16
K140693	Vscan with Dual Probe	GE Medical Sysyems Ultrasound & Primary Care Diagn	IYN	Class II	2014-05-16
K140631	Lumena Fh Hair Removal System	Shaser, Inc.	ONF	Class II	2014-05-16
K140287	Axera Rx Access System	Arstasis, Inc.	DYB	Class II	2014-05-16
K140054	Rescan	ResMed Corp	BZD	Class II	2014-05-16
K133988	Tempus Pro Extended Features	Remote Diagnostic Technologies Ltd.	MWI	Class II	2014-05-16