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 1430 of 3531

510(k) clearances, page 1430 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033172	Candela Gentleyag Family of Laser Systems	Candela Corporation	GEX	Class II	2003-10-30
K033141	Mechanical Wheehchair	Pacific Medical Suppliers, Inc.	IOR	Class I	2003-10-30
K033131	Natural Comfort Double Electric/battery Breast Pump, Model 1181/1068	The First Years, Inc.	HGX	Class II	2003-10-30
K033125	Handivipp	Handinor USA, Inc.	IOR	Class I	2003-10-30
K033016	Pisces Z Quad Lead Model, 3890, Pisces Z Quad Compact Lead Model, 3891, Pisces Z Quad Plus Lead Model, 3892	Medtronic Neuromodulation	GZB	Class II	2003-10-30
K032915	Advantage 4D Option	GE Healthcare	JAK	Class II	2003-10-30
K032798	Dimension Automated Hdl Cholesterol (Ahdl) Flex Reagent Cartridge (Df48a) Catalog # Df48a	Siemens Healthcare Diagnostics Inc.	JHM	Class I	2003-10-30
K032791	Glycohemosure Hba1c Control	Quantimetrix Corp.	GGM	Class II	2003-10-30
K032731	Merlexi Craft Series of Manual (Mechanical) Wheelchairs	Turbo Wheelchair Co., Inc.	IOR	Class I	2003-10-30
K032676	Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar	Ethicon Endo-Surgery Inc	GCJ	Class II	2003-10-30
K032656	Ge Logiq 9 Ultrasound Bt03/iq, Model 2375600-X	GE Med. Systems Ultrasound & Prim. Care Diag.,Llc	IYN	Class II	2003-10-30
K032513	T-Wave Alternans (Twa) Algorithm Option	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2003-10-30
K032499	A & D Medical Lifesource Ua-704 Digital Blood Pressure Monitors	A and D Engineering, Inc.	DXN	Class II	2003-10-30
K032385	Global Press-Fit Stem	Global Medical Co.	LPH	Class II	2003-10-30
K032366	Bonesource Hac Fast Setting Cement	Stryker Corp.	GXP	Class II	2003-10-30
K032105	Endohelix Endarterectomy Device	Endarx, Inc.	DWX	Class II	2003-10-30
K032002	Fertell Female Fertility Test	Genosis, Ltd.	NGA	Class I	2003-10-30
K031838	Profusion Bone Void Filler Kit	Biogeneration	MQV	Class II	2003-10-30
K031819	Dio-Dent 10 Dental Diode Laser	Msq (M2), Ltd.	GEX	Class II	2003-10-30
K031684	Topkin Wound Dressing	Biomet Merck GmbH	QSZ	Unclassified	2003-10-30
K031681	Sterisil Antimicrobial Tubing and Bottle	Sterisil	EIA	Class I	2003-10-30
K031473	Rational Imaging Pacs	Intuitive Imaging Informatics, LLC	LLZ	Class II	2003-10-30
K030082	Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851	Richard Wolf Medical Instruments Corp.	HRX	Class II	2003-10-30
K023509	Dbb-05 Hemodialysis Delivery System	Davita Clinical Research (Trri)	KDI	Class II	2003-10-30
K033326	Philips Plus Computed Tomography System	Philips North America LLC	JAK	Class II	2003-10-29
K033315	Superopen 0.23T, Model Nam-P023a	Neusoft Digital Medical Systems Co., Ltd.	LNH	Class II	2003-10-29
K033311	Aloka Ssd-5000 V5.0 Ultrasound System	Aloka Co., Ltd.	IYN	Class II	2003-10-29
K033140	Neuromuscular Electrical Stimulator, Model Ev-807P	Everyway Medical Instruments Co., Ltd.	IPF	Class II	2003-10-29
K033126	Monarch 21 Penile Plethysmograph System	Behavioral Technology, Inc.	LIL	Unclassified	2003-10-29
K033088	Sectra Ids5 Radiology Workstation Version 10.1	Sectra AB	LLZ	Class II	2003-10-29
K033078	Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-Web03 Software	GE Healthcare	MSX	Class II	2003-10-29
K033065	Synthes 2.0 Mm Craniofacial Locking Plates	Synthes (USA) Products LLC	MQN	Class II	2003-10-29
K032962	Ac 3 Lumen Central Venous Access Kit with Arrowg+ard Antimicrobial Surface	Arrow Intl., Inc.	FOZ	Class II	2003-10-29
K032748	Vitrea2, Version 3.4 Medical Image Processing Software	Canon Medical Informatics, Inc.	LLZ	Class II	2003-10-29
K032660	Xtrak Support Catheter	Xtrak Medical, Inc.	DQY	Class II	2003-10-29
K032599	Medical Laser Technologies, Llc Mtl Erbium:yag Laser System	Medical Laser Technologies Ltd.	GEX	Class II	2003-10-29
K032442	Kls-Martin Mandibular/reconstruction System II	KLS-Martin L.P.	MQN	Class II	2003-10-29
K032405	Given Diagnostic System	Given Imaging Ltd.	NEZ	Class II	2003-10-29
K032387	Trivex System	Smith & Nephew, Inc.	DWQ	Class II	2003-10-29
K032119	Paragon Medical Surgical Instrument Delivery System Various	Paragon Medical Inc.	KCT	Class II	2003-10-29
K032084	Powder-Free Synthetic Vinyl Examination Gloves, Blue Color	Shen Wei (USA), Inc.	LYZ	Class I	2003-10-29
K032024	Powder-Free Nitrile Examination Gloves, Blue Color (Tested for Use with Chemotherapy Drugs)	Shen Wei (USA), Inc.	LZA	Class I	2003-10-29
K031341	Stick Flow	Stick Tech Ltd.	EBF	Class II	2003-10-29
K030120	Amsure Foley Catheter	Amsino International, Inc.	EZL	Class II	2003-10-29
K023000	Home Care Various Models of Powered Muscle Stimulator, Ht-329M Series	Home Care Technology Co., Ltd.	IPF	Class II	2003-10-29
K033295	Butler Nucare Root Conditioner with Novamin	Novamin Technology, Inc.	LBH	Class II	2003-10-28
K033221	Kavo Everest Zh-Blank	Kavo America	EIH	Class II	2003-10-28
K032485	Medtronic Minimed Countach Infusion Set, Model 313	Medtronic, Inc.	FPA	Class II	2003-10-28
K032484	Medtronic Minimed Paradigm Countach Infusion Set, Model Mmt 310	Medtronic, Inc.	FPA	Class II	2003-10-28
K032356	Nxstage System One with Cartridge Express	NxStage Medical Inc	KDI	Class II	2003-10-28