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 961 of 3531

510(k) clearances, page 961 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110807	Abg II Monolithic Hip Stem	Stryker Corp.	MAY	Class II	2011-05-25
K110588	Leucadia Pedicle Screw System	Phygen, LLC	NKB	Class II	2011-05-25
K110473	Nanotack Suture Anchor 1.4Mm	Pivot Medical	MBI	Class II	2011-05-25
K110321	Tiger Spine System	Corelink, LLC	MNH	Class II	2011-05-25
K110251	Synchron Multi Calibrator	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2011-05-25
K110132	Muse Cardiology Information System	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2011-05-25
K103692	Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000	Surgiquest, Inc.	HIF	Class II	2011-05-25
K103514	Pro-V Coat	Bisco Inc	EBG	Class II	2011-05-25
K102894	Classix Chemical Sterilization Indicator	Propper Mfg Co Inc	JOJ	Class II	2011-05-25
K102466	Fujinon Epx-4440Hd Digital Video Processor	FUJIFILM Healthcare Americas Corporation	FET	Class II	2011-05-25
K102463	Good Night	Larry V Connell, Dmd	LRK	Class II	2011-05-25
K092268	Randox Bariturates Assay	Randox Laboratories, Limited	DIS	Class II	2011-05-25
K081868	Smart Leish, Model Lgm1-050	U.S. Army Medical Research Institute of Infectious	OUZ	Class I	2011-05-25
K111384	Lifebridge	Lifebridge Medizintechnik AG	KFM	Class II	2011-05-24
K111336	Ebw Nm 2.0	Philips North America LLC	LLZ	Class II	2011-05-24
K111230	Synthes 3.5Mm Low Profile Cortical Screw	Synthes (USA) Products LLC	HWC	Class II	2011-05-24
K111183	Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)	Orthofix SRL	KWP	Class II	2011-05-24
K111182	Angiojet Solent Omni Thrombectomy Set	Medrad, Inc.	QEZ	Class II	2011-05-24
K111153	Sorbafix (Tm) Absorbable Fixation System, Permafix (Tm) Fixation System	C.R. Bard Inc	GDW	Class II	2011-05-24
K110905	Total Shoulder System	SHOULDER INNOVATIONS, Inc	KWS	Class II	2011-05-24
K110746	4D Lv-Analysis 3.0	TOMTEC Imaging Systems GmbH	DQK	Class II	2011-05-24
K103421	Arstasis Dilator Adapter	Arstasis, Inc.	DRE	Class II	2011-05-24
K102534	Aze Virtualplace-Mr Flow Analysis Software	Aze, Ltd.	LLZ	Class II	2011-05-24
K111154	Selectra Ic-50-60, Selectra Ic-50-75, Selectra Ic-90-65, Selectra Ic-90-75	BIOTRONIK AG	DQY	Class II	2011-05-23
K110792	Gelpoint Path	Applied Medical Resources Corp	FER	Class II	2011-05-23
K110676	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2011-05-23
K110489	Slit Lamp Sl-2G	Topcon Healthcare, Inc.	HJO	Class II	2011-05-23
K110155	Nitrile Powder Free Patient Examination Gloves	Tangshan Xiangrui Plastic Products Co., Ltd.	LZA	Class I	2011-05-23
K103500	Gore Embolic Filter	W. L. Gore & Associates, Inc.	NTE	Class II	2011-05-23
K102199	Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)	Sophono, Inc.	LXB	Class II	2011-05-23
K101037	Eg V1 (Bl) Self Monitoring Glucose Test System Model: Eps10017	Eps Bio Technology Corp.	LFR	Class II	2011-05-23
K111137	Hydrofix Vaso Shield	Mimedx Group, Inc.	OMR	Class II	2011-05-20
K111114	Suresigns Vs2 Vital Signs Monitor	Philips North America LLC	DXN	Class II	2011-05-20
K111052	Syngo Neuro Pbv-Ir	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2011-05-20
K110872	Withings Blood Pressure Monitor	Withings	DXN	Class II	2011-05-20
K110803	Suresigns Vsi Vital Signs Monitor	Philips North America LLC	DXN	Class II	2011-05-20
K110578	Millenium Hx Portable Reverse Osmosis Water Purification System	Evoqua Water Technologies LLC	FIP	Class II	2011-05-20
K110495	Liftkar Pt	Sano Transportgerate GmbH	ING	Class II	2011-05-20
K110182	Cannabinoids Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	LDJ	Class II	2011-05-20
K110166	Clearcut S Safety Knife	Alcon Laboratories	HNN	Class I	2011-05-20
K110015	Vitalsens, Aingeal, V-Pod	Intelesens Limited	MHX	Class II	2011-05-20
K103832	Phoenix Hemodialysis Delivery System	Gambro Renal Products	KDI	Class II	2011-05-20
K103801	Hypothermx Intravenous Fluid Warmer	Emit Corporation	LGZ	Class II	2011-05-20
K103797	K2m Cocr Wire	K2M, Inc	JDQ	Class II	2011-05-20
K103723	Sicat Implant V1.2	Sicat GmbH & Co. KG	LLZ	Class II	2011-05-20
K103603	Zeus Elisa Hsv Gg-2 Igg Test System	Zeus Scientific LLC	MYF	Class II	2011-05-20
K103382	Intercontinental Plate-Spacer	Globus Medical, Inc.	OVD	Class II	2011-05-20
K103207	Jbaids Q Fever Detection Kit	Idaho Technology, Inc.	OVF	Class I	2011-05-20
K103067	Exsalt Sd7 Wound Dressing	Exciton Technologies Inc.	FRO	Unclassified	2011-05-20
K102970	Gyrus Acmi Cyber Wand-Sterilization Trays Model Fgt	Gyrus ACMI, Inc.	KCT	Class II	2011-05-20