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 2026-11-05, 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 2160 of 3531

510(k) clearances, page 2160 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943378	Implex Cement Restrictor System	Implex Corp.	LZN	Class II	1994-09-23
K943321	Quad Pelvis Coil	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-09-23
K943031	Bipolar Electrosurgical Pencil	Boston Surgical Products, Inc.	HQO	Class II	1994-09-23
K942956	Surgical Instruments and Accessories	Stryker Corp.	HWE	Class I	1994-09-23
K942523	Miracle-Ear Impression Material Kit	Miracle-Ear, Inc.	ESD	Class I	1994-09-23
K942306	Irrigation/aspiration Instrument	Megadyne Medical Products, Inc	GCJ	Class II	1994-09-23
K942146	Phoenix Nuclear Medicine Processing Computer	Siemens Medical Solutions USA, Inc.	KPS	Class II	1994-09-23
K936001	Patlak & Fdg Autoradiographic	GE Healthcare	KPS	Class II	1994-09-23
K934610	Cath Dome Pd- Water Resistant Cover for Indwelling Peritoneal Dialysis Catheters and Transfer Sets	Tabex Industries, Inc.	FJS	Class II	1994-09-23
K933445	Dps 100 Multiport Illumination System (Mis)	Storz Instrument Co.	HJM	Class II	1994-09-23
K932501	Varian Origami, Version 1.0	Varian Assoc., Inc.	IYE	Class II	1994-09-23
K930513	Varian Rms-2000, Release 2.5	Varian Assoc., Inc.	IYE	Class II	1994-09-23
K926019	Forarm Opt/norland Xr Series X-Ray Bone Densitomet	Norland Corp.	KGI	Class II	1994-09-23
K943587	Advanced in-Bed Weigh System	Future Systems, Inc.	FRW	Class I	1994-09-22
K942718	Cloth Tens/bnes Electrode	Conmed Andover Medical, Inc.	GXY	Class II	1994-09-22
K934041	Hewlett Packard Conos Ultrasound Imaging System Modification	Hewlett-Packard Co.	IYN	Class II	1994-09-22
K933552	Pm-Pager	Hill Engineering	KMI	Class I	1994-09-22
K933430	Cytoguide Stereotatic Biopsy System	Gold Coast Imaging, Inc.	IZH	Class II	1994-09-22
K932141	Cardiac Catheterization Kit	Abbott Medical	DQO	Class II	1994-09-22
K931509	Geritrex Sterile Saline Solution for Irrigation	Geritrex Corp.	JOL	Class II	1994-09-22
K930017	Pb 7200 Series Ventilatory System W/keyboard	Medtronic, Inc.	CBK	Class II	1994-09-22
K924978	7250 Metabolic Monitor	Medtronic, Inc.	BZL	Class II	1994-09-22
K924043	Auto-PEEP	Medtronic, Inc.	CBK	Class II	1994-09-22
K922975	Model 7200Ae Ventilator (Enhancement)	Medtronic, Inc.	CBK	Class II	1994-09-22
K922705	Model 7200Ae Ventilator	Medtronic, Inc.	CBK	Class II	1994-09-22
K944257	Lionheart 3 Multi-Parameter Simulator	Bio-Tek Instruments, Inc.	DRT	Class II	1994-09-21
K944251	Kendall Modu-Vac Closed Suction System	Kendall Healthcare Products Co. Div.Of Tyco Health	BSY	Class I	1994-09-21
K944135	Urological Guidwire	Applied Medical Resources Corp	KNY	Class II	1994-09-21
K943936	Xlt, Rea Comfort, Spirea, Zoom	Electric Mobility	IOR	Class I	1994-09-21
K943825	Miracle Ear Confidante	Miracle-Ear, Inc.	ESD	Class I	1994-09-21
K943788	Resound Personal Hearing System	Resound Corp.	ESD	Class I	1994-09-21
K943668	Ksea Continous Flow Cystoscope	Karl Storz Endoscopy-America, Inc.	FBO	Class II	1994-09-21
K943613	Nil	Sing Wah International Enterprises, Ltd.	HOI	Class I	1994-09-21
K943584	Presterilized Endodontic Files	Dentsply Intl.	EKJ	Class I	1994-09-21
K942992	Royal Shield Rubber Dams	Elastomade Accessories Sdn Bhd	EIE	Class I	1994-09-21
K942776	Magnetic Resonance Angiography Capability/oe 1.5 S1	Otsuka Electronics USA, Inc.	LNH	Class II	1994-09-21
K942579	Force Gsu System Model No. Gsu-20 and Gsu-22	Medtronic, Inc.	GEI	Class II	1994-09-21
K942191	Uresil Dilator	Uresil, LLC	DYB	Class II	1994-09-21
K941977	Taylor Long Term Monitoring Electrode	Taylor Industries, Inc.	DRX	Class II	1994-09-21
K936152	3M 1152 Laser Imager	3M Information,Imaging and Electronic Sector	LMC	Class II	1994-09-21
K936011	Invamed Reusable Laparoscopic Trocar System	Invamed, Inc.	HET	Class II	1994-09-21
K933639	Imkb Contra-Angles	Micro-Mega SA	EGS	Class I	1994-09-21
K933532	Self Tapping Dental Implant System	Implant Support Systems, Inc.	DZE	Class II	1994-09-21
K932614	Regional Anaesthesia Tray	Mediziv Medical Products, Ltd.	CAZ	Class II	1994-09-21
K944249	Auto Suture* Anti-Fog Device**	United States Surgical, A Division of Tyco Healthc	FEB	Class II	1994-09-20
K944224	Karl Storz Fluid Light Cables	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-09-20
K944055	Forceps, Surgical Gynecological	Owens Precision Systems, Inc.	HCZ	Class II	1994-09-20
K943924	Creatinine-Po Reagent Kit	Synermed, Inc.	CGX	Class II	1994-09-20
K943787	Auratek Fdp	bioMerieux, Inc.	DAP	Class II	1994-09-20
K943463	The Yellow Iris	Intl. Remote Imaging Systems	KQO	Class I	1994-09-20