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 822 of 3530

510(k) clearances, page 822 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131829	Intellivue Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2013-08-16
K131687	6F X 60Cm Triple Pro-Line CT Basic Ir Set	Medical Components, Inc.	LJS	Class II	2013-08-16
K131634	Symbia	Siemens Medical Solutions USA, Inc.	KPS	Class II	2013-08-16
K131325	Quattro Gl Suture Anchor	Cayenne Medical Inc.	MBI	Class II	2013-08-16
K131052	Tubeclear Model 101 (with New Clearing Stem Ne and G Models)	Actuated Medical, Inc.	KNT	Class II	2013-08-16
K130793	Newa Skin Therapy System	Endymion Medical, Ltd.	GEI	Class II	2013-08-16
K130768	Jiajian Cmn Stimulator	Wuxi Jiajian Medical Instrument Co., Ltd	BWK	Unclassified	2013-08-16
K130163	D-Lux	Diadent Group International	EBZ	Class II	2013-08-16
K130160	Verify Process Indicator for Reliance Eps	STERIS Corporation	JOJ	Class II	2013-08-16
K123975	Quickie & Zippie Series	Sunrise Medical, Inc.	IOR	Class I	2013-08-16
K123830	Intermittent Pneumatic Compression Device	Dalian Labtek Science & Development Co Ltd	JOW	Class II	2013-08-16
K123756	Covagen	Covalon Technologies Inc.	KGN	Unclassified	2013-08-16
K123633	Trs Cranial Bone Void Filler(trs C-Bvf)	Tissue Regeneration Systems, Inc.	GXR	Class II	2013-08-16
K123608	Endo E Class	Saeyang Microtech Co., Ltd.	EBW	Class I	2013-08-16
K123605	Smartflow Catheter	Mri Interventions, Inc.	HCA	Class II	2013-08-16
K123604	Abg III Monolithic Hip Stem	Howmedica Osteonics Corp	MAY	Class II	2013-08-16
K123582	Endo a Class	Saeyang Microtech Co., Ltd.	EKX	Class I	2013-08-16
K121736	Perf-Gen Pulsatile Perfusion Solution	Waters Medical Systems LLC	KDL	Class II	2013-08-16
K132341	Dc-8/ Dc-8 Pro/ Dc-8 Cv/ Dc-8 Exp/ Dc-8S Diagnostic Ultrasound Systems	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2013-08-15
K132072	True Metrix Self-Monitoring Blood Glucose System, True Metri Pro Professional Monitoring Blood Glucose System	Trividia Health, Inc.	NBW	Class II	2013-08-15
K131570	Orthovision	Ewoosoft Co., Ltd	LLZ	Class II	2013-08-15
K131478	Contrast Conservation System	Osprey Medical, Inc.	DXT	Class II	2013-08-15
K131351	Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CJE	Class II	2013-08-15
K131144	Ameco Sheath Introducer	Ameco Medical Industries	DYB	Class II	2013-08-15
K131063	Amplatzer Torq Vue Lp Delivery System	Abbott Medical	DQY	Class II	2013-08-15
K130832	Orthohelix Staple System	TORNIER Inc.	JDR	Class II	2013-08-15
K130779	Lvivo Ef System	Diacardio, Ltd.	LLZ	Class II	2013-08-15
K130752	Dynasense System	Centauri Medical, Inc.	KMI	Class I	2013-08-15
K130687	2F & 3F Vascu-Sheath Tearaway Introducer	Medical Components, Inc.	DYB	Class II	2013-08-15
K130392	Kinex Bioactive	Globus Medical, Inc.	MQV	Class II	2013-08-15
K130299	Gmk Hinge	Medacta International SA	KRO	Class II	2013-08-15
K130074	Gymform ABS-a-Round	Well Brain International, Ltd.	NGX	Class II	2013-08-15
K123988	Anyonetm Internal Implant System	Megagen Implant Co., Ltd.	DZE	Class II	2013-08-15
K123766	Novopen Echo, a Dial a Dose Insulin Delivery Pen	Novo Nordisk a/S	FMF	Class II	2013-08-15
K122181	Ebchek Blood Glucose Monitoring System	Visgeneer, Inc.	NBW	Class II	2013-08-15
K132200	Pro Hmpv+ Assay	Gen-Probe Prodesse, Inc.	OEM	Class II	2013-08-14
K132159	Proadeno+ Assay	Gen-Probe Prodesse, Inc.	OCC	Class II	2013-08-14
K131951	Irix-C Cervical Integrated Fusion System	Xtant Medical Holdings, Inc.	OVE	Class II	2013-08-14
K131870	Glide Device	Home Skinovations, Ltd.	OHT	Class II	2013-08-14
K131515	Ace -Gt Reagent; Ace Lipase Ragent; Ace T4 Reagent	Alfa Wassermann	KLI	Class II	2013-08-14
K131425	Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter	Medtronic Navigation, Inc	OLO	Class II	2013-08-14
K131247	Multibolus II Disposable Pain Management System	Mfs - Medical Flow Systems, Ltd.	MEB	Class II	2013-08-14
K130948	C-Fuse Cervical Intervertebral Body Fusion System	Southern Spine, LLC	ODP	Class II	2013-08-14
K130693	Aeu-525 Transport III Portable Dental System	Aseptico, Inc.	ELC	Class II	2013-08-14
K130602	Lasso Nav Duo Loop Catheter	Biosense Webster Inc	DRF	Class II	2013-08-14
K130421	Meron Application Capsules	Voco GmbH	EMA	Class II	2013-08-14
K123882	Age Automatic Upper Arm Blood Pressure Monitor	Ageless Health Industrial Co., Ltd.	DXN	Class II	2013-08-14
K131464	Extricare Npwt Foot Dressing	Devon Medical, Inc.	OMP	Class II	2013-08-13
K130900	Evicel Application Device	Ethicon Inc (on Behalf of Omrix Biopharaceuticals	FMF	Class II	2013-08-13
K130887	S4c Navigation Instruments	Aesculap Implant System, Inc.	OLO	Class II	2013-08-13