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 761 of 3530

510(k) clearances, page 761 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141061	Remoteye Viewer	Neologica S.r.l.	LLZ	Class II	2014-08-01
K141059	Natural Rubber Latex Male Condoms	Karex Industries Sdn Bhd	HIS	Class II	2014-08-01
K141058	Ensizor Endoscopic Scissors	Slater Endoscopy, LLC	OCZ	Class II	2014-08-01
K140953	Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter	ConvaTec Limited	KOD	Class II	2014-08-01
K140551	Perkinelmer, Xrpad 4336 Med Flat Panel Detector	Revvity Health Sciences, Inc.	MQB	Class II	2014-08-01
K140100	True Metrix Self-Monitoring Blood Glucose System, True Metrix Pro Professional Monitoring Blood Glucose System	Trividia Health, Inc.	NBW	Class II	2014-08-01
K133942	Endoscope Sterilization Tray	Intuitive Surgical, Inc.	KCT	Class II	2014-08-01
K133847	Sensititre Haemophilus / Streptococcus Pneumoniae (Hp) Susceptibility Plates	Thermo Fisher Scientific Oy	JWY	Class II	2014-08-01
K133484	Zoll X Series	ZOLL Medical Corporation	MKJ	Class III	2014-08-01
K133461	Stryker Universal Orbital Floor System	Stryker Corp.	JEY	Class II	2014-08-01
K132892	Tebco-W	Bomed, Inc.	DXG	Class II	2014-08-01
K132662	Passport Series Patient Monitors	Shenzhen Mindray Biomedical Electronics Co., Ltd.	MHX	Class II	2014-08-01
K141832	3T 16Ch Flex Speeder, Medium , 3T 16Ch Flex Speeder, Large	NeoCoil, LLC	MOS	Class II	2014-07-31
K141672	Digiarc 100Au+	Beijing East Whale Imaging Technology Co., Ltd.	OXO	Class II	2014-07-31
K141475	Endosize	Therenva SAS	LLZ	Class II	2014-07-31
K140894	Argen Pmma	The Argen Corporation	EBG	Class II	2014-07-31
K140603	Onepass Endoscopic Vessel Harvesting Sysyetm	Saphena Medical, Inc.	GEI	Class II	2014-07-31
K140527	Sensilight Mini	El Global Trade Ltd.	OHT	Class II	2014-07-31
K140279	S9 Greenhills	ResMed Corp	BZD	Class II	2014-07-31
K133725	Traxcess 14 Guidewire	Terumo Cardiovascular Systems Corporation	MOF	Class II	2014-07-31
K132293	Syvek Radial Band	Marine Polymer Technologies, Inc.	DXC	Class II	2014-07-31
K102973	Silver Dental Arrest	Cooley Consulting, Inc.	PHR	Class II	2014-07-31
K141778	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp	GAM	Class II	2014-07-30
K141484	Open Fmsealer	Omni-Guide Holdings, Inc.	GEI	Class II	2014-07-30
K141254	Elcam Stopcocks and Manifolds	Elcam Medical A.C.A.L.	FMG	Class II	2014-07-30
K141145	Liberty Pdx Cycler	Fresenius Medical Care Renal Therapies Group, LLC	FKX	Class II	2014-07-30
K141130	Encompass	Panoramic Corp.	MUH	Class II	2014-07-30
K141026	Leaderflex	Vygon	FOZ	Class II	2014-07-30
K141011	G-Force Gen 2 Suture Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	2014-07-30
K141001	Alpine Hip Stem; Alpine Ha Hip Stem	Ortho Development Corp.	LPH	Class II	2014-07-30
K140883	Vanguard 360 Osseoti Tibial Sleeve Augment	Zimmer GmbH	MBH	Class II	2014-07-30
K140302	Optetrak Logic Porous Femoral Components	Exactech, Inc.	MBH	Class II	2014-07-30
K133402	K2m Modular Hooks	K2m, Inc.	NKB	Class II	2014-07-30
K133311	Endoled	Olympus Winter & Ibe GmbH	NTN	Class II	2014-07-30
K132912	Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant	In2Bones SAS	HWC	Class II	2014-07-30
K132797	L'disq	CG MedTech Co., Ltd.	GEI	Class II	2014-07-30
K132709	Vr Medical Heat and Moisture Exchanger and Filter	Vr Medical	CAH	Class II	2014-07-30
K132516	Oxiprobe E (Oxiprobe)	Bio Medical Technologies Co., Ltd.	DQA	Class II	2014-07-30
K132353	Suction Lipoplasty Accessories	Inex	QPB	Class II	2014-07-30
K141797	Alteon 6.5Mm Bone Screws	Exactech, Inc.	LPH	Class II	2014-07-29
K141749	Carefine Pen Needle Family Including Quintapoint and Superpoint	Facet Technologies, LLC.	FMI	Class II	2014-07-29
K141167	Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library)	VitalConnect, Inc.	DRG	Class II	2014-07-29
K141120	Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System	ZimVie US Corp LLC	NHA	Class II	2014-07-29
K141119	Camera Enabled Probe	Trice Medical	HRX	Class II	2014-07-29
K141109	Aperio Epathology Eihc IVD System	Leica Biosystems Imaging, Inc.	NOT	Class II	2014-07-29
K140500	Skintact	Leonhard Lang GmbH	GEI	Class II	2014-07-29
K140431	Pediloc Fragment System	Orthopediatrics Corp	HRS	Class II	2014-07-29
K133947	Irix-a Lumbar Integrated Fusion System	Xtant Medical Holdings, Inc.	OVD	Class II	2014-07-29
K133840	Kangli Locking Plate System	Suzhou Kangli Orthopaedics Instrument Co., Ltd.	HRS	Class II	2014-07-29
K141728	Ace Calibrator	Sentinel CH SpA	JIT	Class II	2014-07-28