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 740 of 3530

510(k) clearances, page 740 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K142168	Nature's Bond 600 and Nature's Bond 603	Devon Medical Products	HGX	Class II	2014-12-04
K142122	Radar Vascular Compression Device	Advanced Vascular Dynamics	DXC	Class II	2014-12-04
K141632	Zevo (Tm) Anterior Cervical Plate System	Medtronic Sofamor Danek USA Inc	KWQ	Class II	2014-12-04
K141613	Goldenline Powder-Free White Vinyl Patient Examination Gloves	Zibo Goldenline Plastic Product Co., Ltd.	LYZ	Class I	2014-12-04
K141105	Pulse Oximeter	Hunan Accurate Bio-Medical Technology Co., Ltd.	DQA	Class II	2014-12-04
K141092	Mark3	Cavex Holland B.V.	ELW	Class II	2014-12-04
K141064	Vesoflow Plus Dvt Compression Device	Caremed Supply, Inc.	JOW	Class II	2014-12-04
K140657	Curos Red Port Protector	Ivera Medical, Inc.	QBP	Class II	2014-12-04
K140285	B Travelsavvy Sharps Container	Bellegrove Medical Supply, Inc.	MMK	Class II	2014-12-04
K143217	12 mm & Stapler Bladeless Obturators	Intuitive Surgical, Inc.	NAY	Class II	2014-12-03
K143144	ST AIA-PACK PROG II Calibrator Set	Tosoh Bioscience Inc	JIT	Class II	2014-12-03
K143057	M3290B Philips IntelliVue Information Center iX	Philips North America LLC	MSX	Class II	2014-12-03
K142915	ZOLL X Series	ZOLL Medical Corporation	MKJ	Class III	2014-12-03
K142672	AliveCor Heart Monitor	AliveCor	DXH	Class II	2014-12-03
K142288	MAC 800 Resting ECG Analysis System	GE Medical Systems China Co., Ltd.	DPS	Class II	2014-12-03
K141978	Maxpower Relief	Omron Healthcare Co., Ltd.	NUH	Class II	2014-12-03
K141529	Alviguide Blue+ Interventional Cardiology Guiding Catheter	Alvimedica Tibbi Urunler Sanayi ve Dis Ticaret A.S	DQY	Class II	2014-12-03
K141412	Sterilucent Self-Seal Sterilization Pouch	Gs Medical Packaging, Inc.	FRG	Class II	2014-12-03
K141287	Huikang Nitrile Powder Free Patient Exam Gloves, Blue Color	Huikang Glove Co., Ltd.	LZA	Class I	2014-12-03
K141279	Wanghui Nitrile Powder Free Patient Examination Gloves, Blue Color	Wanghui Glove Co., Ltd.	LZA	Class I	2014-12-03
K141020	Surveyor S4 Mobile Monitor	Mortara Instrument, Inc.	DRG	Class II	2014-12-03
K140926	Inmode Wmface Device	Inmode MD, Ltd.	GEI	Class II	2014-12-03
K140920	Syngo.ct Colonography	Siemens Medical Solutions USA, Inc.	NWE	Class II	2014-12-03
K140589	Sterrad Cyclesure 24 Plus Biological Indicator	Mesa Laboratories Inc	FRC	Class II	2014-12-03
K133924	Endoluminal Occlusion System (Eos)	Artventive Medical Group, Inc.	KRD	Class II	2014-12-03
K133502	5000Z Firefly System	Prizm Medical, Inc.	NUH	Class II	2014-12-03
K133496	X Twin System	Roesys GmbH	KPR	Class II	2014-12-03
K133373	Clearview	Neusoft Medical Systems Co., Ltd.	JAK	Class II	2014-12-03
K143164	ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set	Kimberly-Clark Corporation	BSO	Class II	2014-12-02
K142803	Skintact, various other tradenames	Leonhard Lang GmbH	MKJ	Class III	2014-12-02
K142340	Infrared Therapy System	Beijing Huatai Healthcare Technology Co., Ltd.	ILY	Class II	2014-12-02
K142310	Stryker Infrared Fluorescence (IRF) Imaging System	Stryker Corp.	OWN	Class II	2014-12-02
K142069	Gmk Extension	Medacta International SA	JWH	Class II	2014-12-02
K141862	Health2sync Mobile Application, Health2sync Smart Cable	H2, Inc.	NBW	Class II	2014-12-02
K141282	Pgs 5.5 Mm Cannulated Pedicle Screw	Pinnacle Spine Group, LLC	NKB	Class II	2014-12-02
K140796	Medusa Vascular Plug,	Endoshape, Inc.	KRD	Class II	2014-12-02
K140296	Clearlumen Thrombectomy System	Walk Vascular, LLC	QEZ	Class II	2014-12-02
K140290	Stoploss Jones Tube	Ljt Surgical, Ltd.	OKS	Unclassified	2014-12-02
K143141	CD HORIZON Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2014-12-01
K142973	Resolution Clip	Boston Scientific Corporation	PKL	Class II	2014-12-01
K142917	Bp652n (Hem-6300-Z)	Omron Healthcare Co., Ltd.	DXN	Class II	2014-12-01
K142591	CD HORIZON Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2014-12-01
K142580	Chemtrue Multi-Panel DOA DIP Card Tests	Chemtron Biotech, Inc.	DKZ	Class II	2014-12-01
K142573	HairMax LaserComb, HairMax LaserComb	Lexington International, LLC	OAP	Class II	2014-12-01
K142521	Synapse 3D Liver and Kidney Analysis	Fujifilm Meidcal Systems U.S.A.,Inc.	LLZ	Class II	2014-12-01
K142471	Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip	Pressure Point, Inc.	MVV	Unclassified	2014-12-01
K142285	AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz	AmeriWater LLC.	FIP	Class II	2014-12-01
K141135	Juliet Ll	Spineart SA	MAX	Class II	2014-12-01
K133994	Sivr56-T Kit	Barco N.V.	DXJ	Class II	2014-12-01
K143066	Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers	Zimmer GmbH	HRS	Class II	2014-11-28