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 2026-10-29, 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 800 of 3530

510(k) clearances, page 800 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133169	Meso Tendon Matrix	Kensey Nash Corporation dba Dsm Biomedical	OWY	Class II	2013-12-20
K133078	K-Etchant Syringe; Needle Tip (E)	Kuraray Noritake Dental, Inc.	KLE	Class II	2013-12-20
K133052	Affix(r) Next Gen Spinous Process Plate System	NuVasive Inc	PEK	Class II	2013-12-20
K132998	Wandy Self-Adhesive Electrodes	Wandy Rubber Industrial Co., Ltd	GXY	Class II	2013-12-20
K132917	Ocular Force Gauge	Ocular Therapeutix, Inc.	HKY	Class II	2013-12-20
K132887	Airfit N10	ResMed Corp	BZD	Class II	2013-12-20
K132790	Infix Anterior Lumbar System	Zimmer Spine, Inc.	MAX	Class II	2013-12-20
K132776	Seal Biopsy Valve - Reusable	Boston Scientific Corporation	OCX	Class II	2013-12-20
K132715	Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens	Bausch & Lomb Incorporated	LPL	Class II	2013-12-20
K132708	Biomarc Fiducial Marker	Carbon Medical Technologies, Inc.	NEU	Class II	2013-12-20
K132671	Stryker Neptune 2 Waste Managment System	Stryker Corp.	JCX	Class II	2013-12-20
K132652	Via Microcatheter, via Plus Microcatheter	Sequent Medical, Inc.	DQY	Class II	2013-12-20
K132646	Sunetics Clinical Bio-Stimulation Laser	Sunetics International Marketing Group, LLC	OAP	Class II	2013-12-20
K132555	Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit	The Binding Site	PCN	Class II	2013-12-20
K132530	Ge Datex-Ohmeda Aisys Cs2 (Aisys Cs^2)	GE Healthcare	BSZ	Class II	2013-12-20
K132428	Ideal	Jiangsu Ideal Medical Science & Technology Co., LT	HSB	Class II	2013-12-20
K132342	Xvweb	Apteryx, Inc.	LLZ	Class II	2013-12-20
K132329	Nivatopic Plus	Nivagen Pharmaceuticals, Inc.	FRO	Unclassified	2013-12-20
K132243	Barle Tissue Adhesive 2	Advanced Medical Solutions (Plymouth), Ltd.	MPN	Class II	2013-12-20
K132067	Multi Angled Abutment System	Hiossen, Inc.	NHA	Class II	2013-12-20
K132026	V Series Monitoring System, 12.1 Dcu/v12 and 21.0 Dcu/v21	Datascope Corp.	MHX	Class II	2013-12-20
K131953	Image1 Spies	Karl Storz Endoscopy-America, Inc.	FET	Class II	2013-12-20
K131935	Elisio-H Hemodialyzer, Elisio-M Hemodialyzer	Nipro Medical Corporation	KDI	Class II	2013-12-20
K131933	Electronic Pulse Massager	Gurin Products LLC	NUH	Class II	2013-12-20
K131879	Kc 300 Surgical Mask	Kimberly-Clark Corporation	FXX	Class II	2013-12-20
K131765	Ecom Endotracheal Cardiac Output Monitor System	ConMed Corporation	DSB	Class II	2013-12-20
K131510	Polydimethylsiloxane Impression Material	Blackwell Device Consulting	ELW	Class II	2013-12-20
K130691	Electrotherapy Device (Combo Unit)	Guangzhou Finecure Medical Equipment Co.,Ltd	IPF	Class II	2013-12-20
K130284	On Call Sharp Blood Glucose Monitoring System	Acon Laboratories, Inc.	NBW	Class II	2013-12-20
K130208	Bernoulli Enterprise Software	Cardiopulmonary Corp.	MHX	Class II	2013-12-20
K130082	Genprime Drugs of Abuse Reader System	Genprime, Inc.	DKZ	Class II	2013-12-20
K130052	Tone-a-Matic	Tone-a-Matic International, Inc.	IPF	Class II	2013-12-20
K123006	Air Barrier System (ABS)	Nimbic Systems, Inc.	ORC	Class II	2013-12-20
K122162	Aggreguide	Aggredyne, Inc.	JOZ	Class II	2013-12-20
K133561	Venacure Evlt Nevertouch Procedure Kit, Venacure Evlt Tre' Sheath	Boston Scientific Corporation	GEX	Class II	2013-12-19
K133511	21.3 Inch(54 Cm) Monochrome Lcd Monitor Ms25i2(ml21025)	JVCKENWOOD Corporation	LLZ	Class II	2013-12-19
K133475	Struxxure Anterior Cervical Plate and Screws	Nexxt Spine LLC	KWQ	Class II	2013-12-19
K133346	Smartlog Diabetes Management Software	I-SENS, Inc.	NBW	Class II	2013-12-19
K132952	Microplex Coil System (Mcs), Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2013-12-19
K132837	Lina Powerblade Plus	LiNA Medical Inc	GEI	Class II	2013-12-19
K132794	Smartvest Airway Clearance System	Electromed, Inc.	BYI	Class II	2013-12-19
K132623	Medtronic Confida Brecker Curve Guidewire	Medtronic, Inc.	DQX	Class II	2013-12-19
K132400	Lp(a) Calibrators, and Lp(a) Controls	Biokit, S.A.	JIT	Class II	2013-12-19
K132368	Vapor Ceramic Bracket	Orthodontic Design and Production, Inc.	NJM	Class II	2013-12-19
K132086	On Call Express Blood Glucose Monitoring System	Acon Laboratories, Inc.	NBW	Class II	2013-12-19
K131381	Elisio-H Hemodialyzer	Nipro Medical Corporation	KDI	Class II	2013-12-19
K130611	Entuit Thrive Balloon Retention Gastrostomy Feeding Tube	Xeridiem Medical Devices	KNT	Class II	2013-12-19
K130579	Physoft Ams	Physicians Software Systems, LLC	MQS	Class II	2013-12-19
K124064	Young Again	Espansione Marketing SpA	OHS	Class II	2013-12-19
K123209	Softvue	Delphinus Medical Technologies, Inc.	IYO	Class II	2013-12-19