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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 432 of 3528

510(k) clearances, page 432 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192762	Physio Flex Annuloplasty Ring	Edwards Lifesciences LLC	KRH	Class II	2019-12-16
K192744	CORRIDOR Fixation System	Globus Medical, Inc.	MRW	Unclassified	2019-12-16
K192539	Deka Luxea	El.en. Electronic Engineering SpA	GEX	Class II	2019-12-16
K191834	Stand-Alone ALIF Titanium System	Life Spine	OVD	Class II	2019-12-16
K191751	EM Provisional	Hiossen, Inc.	DZE	Class II	2019-12-16
K191306	Llis, Vittra APS	Dentscare Ltda	EBF	Class II	2019-12-16
K190903	Lawson Retrograde Nephrostomy Wire Puncture Set	Cook Incorporated	LJE	Unclassified	2019-12-16
K190394	SunClear Aligner system	Sun Dental Laboratories LLC	NXC	Class II	2019-12-16
K181548	Pantheon Spinal Pontus Interbody Fusion Device	Pantheon Spinal LLC	MAX	Class II	2019-12-16
K190833	AXS Vecta Aspiration Catheter	Stryker Corp.	DQY	Class II	2019-12-15
K192356	Airlock Centrolock Osteosynthesis Implant System	Novastep	HRS	Class II	2019-12-14
K193344	Tri-Ex Extraction Balloon with Multiple Sizing	Wilson-Cook Medical Inc.	GCA	Class II	2019-12-13
K193317	CoreLite X-Ray Specimen Cabinet	Cirdan Imaging Limited	MWP	Class II	2019-12-13
K193202	EXALT Model D Single-Use Duodenoscope, EXALT Controller	Boston Scientific Corporation	FDT	Class II	2019-12-13
K193194	CrossTorq 14 Guidewire	Scientia Cardio Access, LLC	DQX	Class II	2019-12-13
K193173	CareView 1800Le	Careray Digital Medical System Co., Ltd.	MQB	Class II	2019-12-13
K193170	Deep Learning Image Reconstruction	GE Healthcare Japan Corporation	JAK	Class II	2019-12-13
K193162	EPi-Sense Guided Coagulation System with VisiTrax	AtriCure, Inc.	OCL	Class II	2019-12-13
K193148	VaPro Plus Pocket, VaPro Plus	Hollister Incorporated	GBM	Class II	2019-12-13
K192829	Demetra BDEM-01 Dermatoscope	Barco N.V.	PSN	Class II	2019-12-13
K192647	neria guard Infusion Set	Unomedical A/S	FPA	Class II	2019-12-13
K192627	Laser Hair Growth Cap	Shang FA Biotechnology Co.	OAP	Class II	2019-12-13
K192569	Diode Laser Therapy System	San HE Lefis Electronics Co., Ltd.	GEX	Class II	2019-12-13
K192554	decimal3D	.Decimal, Inc.	MUJ	Class II	2019-12-13
K192531	QyScore Software	Qynapse	LLZ	Class II	2019-12-13
K192370	MEDRAD Stellant FLEX CT Injection System with Certegra Workstation	Medrad, Inc.	DXT	Class II	2019-12-13
K192362	Aero Blue Performance Surgical Gowns	O&M Halyard, Inc.	FYA	Class II	2019-12-13
K192220	ReliOn Premier Classic Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2019-12-13
K192152	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2019-12-13
K192130	Icobrain	icometrix	LLZ	Class II	2019-12-13
K191796	Neo Cage System	Neo Medical, Inc.	MAX	Class II	2019-12-13
K191118	Avanti Distal Radius and Forearm System	Avanti Orthopaedics LLC	HRS	Class II	2019-12-13
K191106	C50 and C80 Multi-parameter Patient Monitor	Shenzhen Comen Medical Instruments Co., Ltd.	MHX	Class II	2019-12-13
K190752	Satisfaite	Femmepharma Consumer Healthcare, LLC	NUC	Class II	2019-12-13
K190742	Epiflo-28	Neogenix, LLC dba Ogenix	KPJ	Class II	2019-12-13
K190738	MyShoulder Placement Guides	Medacta International SA	PHX	Class II	2019-12-13
K190717	Infrared Thermometer, model: PC808	Shenzhen Pacom Medical Instruments Co., Ltd.	FLL	Class II	2019-12-13
K190715	EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand	Interscope, Inc.	ERL	Class II	2019-12-13
K183424	Ambar, Ambar APS, Ambar Universal APS	Dentscare Ltda	KLE	Class II	2019-12-13
K182731	Corelink Navigation Instruments	Corelink, LLC	OLO	Class II	2019-12-13
DEN190034	Control-IQ Technology	Tandem Diabetes Care, Inc.	QJI	Class II	2019-12-13
K193157	Arthrex 3.9mm Corkscrew Suture Anchor	Arthrex GmbH	MAI	Class II	2019-12-12
K193133	Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set	Cook Incorporated	JOH	Class II	2019-12-12
K192938	Invictus™ Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2019-12-12
K192505	HS50/HS60 Diagnostics Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2019-12-12
K192340	OptoMonitor	Opsens Inc.	DXO	Class II	2019-12-12
K191163	Lumax Guiding Catheter	Cook Incorporated	DQY	Class II	2019-12-12
K190793	Tablo Hemodialysis System, Tablo Cartridge	Outset Medical, Inc.	KDI	Class II	2019-12-12
K190673	Health Expert Electronic Stimulator	Shenzhen Osto Technology Company Limited	NUH	Class II	2019-12-12
K190537	BIO-C Sealer Ion+	Angelus Industria de Produtos Odontologicos S/A	KIF	Class II	2019-12-12