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 989 of 3531

510(k) clearances, page 989 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101413	Euromi Eva Sp6	Euromi S.A.	QPB	Class II	2010-12-16
K101363	Vu Cpod Intervertebral Bodu Fusion Device	Musculoskeletal Clinical Regulatory Advisers	ODP	Class II	2010-12-16
K100646	Affinity Pixie Arterial Filter with Balance Biosurface	Medtronic, Inc.	DTM	Class II	2010-12-16
K093299	Synthes Orthodontic Bone Anchor System	Synthes (USA) Products LLC	OAT	Class II	2010-12-16
K102956	V.a.c. Granufoam Silver Small Dressing; V.a.c. Granufoam Silver Medium Dressing; V.a.c. Granufoam Silver Large Dressing	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2010-12-15
K102796	Angiodynamics, Inc. Venacure Procedure Kit	Boston Scientific Corporation	GEX	Class II	2010-12-15
K102201	Contours Lapidus Plating System	Orthofix SRL	HRS	Class II	2010-12-15
K101996	Depuy Global Unite Shoulder System	Depuy (Ireland)	PHX	Class II	2010-12-15
K101118	Activon Tulle	Calidad Solutions, Inc.	FRO	Unclassified	2010-12-15
K101012	V-Trust Handheld Pulse Oximeter Model: Td-8201	Taidoc Technology Corporation	DQA	Class II	2010-12-15
K100999	Immunocap Allergen F20, Almond Model: 14-4179-01	Phadia AB	DHB	Class II	2010-12-15
K100525	Elitech Clinical Systems Glucose Pap Sl Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol 1 and 2	VitalScientific	CGA	Class II	2010-12-15
K100103	Specialty Assayed Control-2	Helena Laboratories, Corp.	GGC	Class II	2010-12-15
K100060	Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475	Vital Diagnostics (Manufacturing) Ptyltd	KHS	Class II	2010-12-15
K103374	Inbone Total Ankle System Model 200347902	Wrightmedicaltechnologyinc	HSN	Class II	2010-12-14
K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	OUR	Class II	2010-12-14
K102734	Comfort Standing Wheelchair, Hero Series	Comfort Orthopedic Co., Ltd.	IPL	Class II	2010-12-14
K100780	Vital Sutures, Suturex, Cirugia Peruana	Unilene, Sac	NEW	Class II	2010-12-14
K100372	Safect Model Ver 1.0	Medic Vision Brain Technologies, Ltd.	LLZ	Class II	2010-12-14
K103459	Vascutrak Pta Dilatation Catheter	C.R. Bard Inc	PNO	Class II	2010-12-13
K103419	Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids Tm	Exactech, Inc.	KWS	Class II	2010-12-13
K102976	Powdered Vinyl Patient Examiniation Gloves, Clear (Non-Colored)	Heze Juxinyuan Food Co., Ltd.	LYZ	Class I	2010-12-13
K102896	Trabecular Metal Tibial Cone Augments	Zimmer Trabecular Metal Technology, Inc.	MBH	Class II	2010-12-13
K102718	Digital Thermometer; Digital Thermometer	International Regulatory Consultants, LLC (Irc)	FLL	Class II	2010-12-13
K102660	Bioraptor Curved 2.3 Pk Suture Anchors	Smith & Nephew Endoscopy, Inc.	MBI	Class II	2010-12-13
K102061	Trevair Chair Adult	Patmont Motor Werks, Inc.	IOR	Class I	2010-12-13
K101465	Straumann Cares Bridge; Straumann Cares Dolder Bar	Straumann USA, LLC	NHA	Class II	2010-12-13
K100779	Sustain Space Maintenance System	Medtronic Sofamor Danek USA Inc	JEY	Class II	2010-12-13
K100700	Med-Rx Pediatric Feeding Tubes and Accessories	Canadian Hospital Specialties Ltd.	FPD	Class II	2010-12-13
K100205	Frontier Devices Neuro System	Folsom Metal Products, Inc.	GWO	Class II	2010-12-13
K103344	Infusion Sets	Abbott Medical	FPA	Class II	2010-12-10
K103311	U by Kotex Click Unscented Menstrul Tampons	Kimberly-Clark Corporation	HEB	Class II	2010-12-10
K103247	Vascucomp	Thermotek, Inc.	JOW	Class II	2010-12-10
K103034	Genesys Spine Interbody Fusion System	Genesys Spine	MAX	Class II	2010-12-10
K103008	Inzone Detachment System	Boston Scientific Corporation	HCG	Class II	2010-12-10
K102749	Quanta Cyber Tm 150W	Quanta System Inc.	GEX	Class II	2010-12-10
K102658	Minispacer Dual-Spray Mdi Adapter with 22Mm (or 15Mm) Od / 22Mm Od/id Connections / 15Mm Id Connections	Thayer Medical Corportation	CAF	Class II	2010-12-10
K102645	Willow/elm Pta Balloon Dilatation Catheter	Creagh Medical Ltd.	LIT	Class II	2010-12-10
K102618	Ventstar Heated, Infinity Id Breathing Circuit Heated	Draeger Medical AG & Co. KG	BTT	Class II	2010-12-10
K102537	Aptus 1.5 Trilock	Medartis AG	HRS	Class II	2010-12-10
K102488	Apex Spine System W/ Cocr Rods	Spinecraft LLC	MNH	Class II	2010-12-10
K102224	Pixi Pediatric Mask	ResMed Corp	BZD	Class II	2010-12-10
K102187	Rii Infrared Ear Thermometer,	Radiant Innovation Inc.	FLL	Class II	2010-12-10
K102166	Electro Interstitial Scan	LD Technology LLC	GZO	Class II	2010-12-10
K101520	Enseal Tissue Sealing Devices Model: Nseal514h-535H, Nseal514rh-535Rh	Ethicon Endo-Surgery Inc	GEI	Class II	2010-12-10
K101433	Depuy Attune Knee System	Depuy Orthopaedics Inc.	OIY	Class II	2010-12-10
K101003	Rapidvit Blast, Rapidwarm Blast	Vitrolife Sweden AB	MQL	Class II	2010-12-10
K100858	Lima-Lio Smr Shoulder System - Humeral Stems, Lima-Lio Smr Shoulder System - Humeral Bodies,	Lima-Lto S.p.A.	KWT	Class II	2010-12-10
K100777	Abl837 Flex Analyzer	Radiometer Medical ApS	CHL	Class II	2010-12-10
K100261	Primatrix Ag Antimicrobial Dermal Dermal Repair Scaffold	Integra LifeSciences Braintree Inc.	FRO	Unclassified	2010-12-10