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 886 of 3530

510(k) clearances, page 886 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122095	Icp Triagemanager	Emergo Europe Consulting	DRG	Class II	2012-07-26
K121982	Sovereign Spinal System	Medtronic Sofamor Danek	OVD	Class II	2012-07-26
K121950	Microtargeting Xl Star Drive System	FHC, Inc.	HAW	Class II	2012-07-26
K121937	E-Cube Inno	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2012-07-26
K121922	Beacon Stabilization System	Globus Medical, Inc.	NKB	Class II	2012-07-26
K121909	Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/cardiotomy Reservior	Corcym Inc.	DTZ	Class II	2012-07-26
K121905	Alere Pbp2a Test	Alere Scarborough, Inc.	MYI	Class II	2012-07-26
K121888	E-Cube 15	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYO	Class II	2012-07-26
K121553	Aquilion Rxl	Toshibamedical Systems Corporation	JAK	Class II	2012-07-26
K121512	Scout Sport Otoacoustic Emissions Measurement System	Bio-Logic Systems Corp.	EWO	Class II	2012-07-26
K121303	Mobile C-Arm	Canon Inc. -Medical Equipment Group	OXO	Class II	2012-07-26
K121293	Cs-Series-Fp with 3030+Option	Omega Medical Imaging, LLC	JAA	Class II	2012-07-26
K121190	Contour Next Blood Glucose Meter	Medrad, Inc.	LFR	Class II	2012-07-26
K121183	Comprehensive Reverse Shoulder - E1 Polyethylene Claims	Zimmer GmbH	PHX	Class II	2012-07-26
K121075	Nervevision Software Systems	3D Imaging Partners, Inc.	LLZ	Class II	2012-07-26
K121013	Connex Vital Signs Monitor 6000 Series	Welch Allyn Inc	MWI	Class II	2012-07-26
K120993	Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	2012-07-26
K120896	Wi-Fi Body Scale	Andon Health Co., Ltd	MNW	Class II	2012-07-26
K120753	Clarisct	Icrco, Inc.	OAS	Class II	2012-07-26
K120509	Stryker All Suture Anchors	Stryker Corp.	MBI	Class II	2012-07-26
K120016	Pioneer Sternal Assist Implant System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HRS	Class II	2012-07-26
K113869	Origen Reinforced Dual Lumen Catheter	OriGen Biomedical, Inc.	DWF	Class II	2012-07-26
K113656	Careguide Oximeter	Reflectance Medical, Inc.	MUD	Class II	2012-07-26
K113397	Zeus Elisa Borrelia Vlse-1/Pepc10 Igg/igm Test System	Zeus Scientific LLC	LSR	Class II	2012-07-26
K113285	Ldr Spine USA Avenue L Interbody Fusion	Ldr Spine USA	OVD	Class II	2012-07-26
K112391	Fujinon Colonoscopes	FUJIFILM Healthcare Americas Corporation	FDF	Class II	2012-07-26
K111260	A/c Enzymatic Vitamin B6 Assay	Anticancer, Inc.	CDD	Class II	2012-07-26
K110898	S.c.o.r.e.s. Unit	Ammed Surgical Equipment, LLC	KCT	Class II	2012-07-26
K121908	Safety Infusion Set	Greiner Bio-One North America, Inc.	FMI	Class II	2012-07-25
K121852	Synthes Zero-P Variable Angle (Va)	Synthes Spine Co.Lp	OVE	Class II	2012-07-25
K121583	Clearfil Majesty Flow	Kuraray Noritake Dental, Inc.	EBF	Class II	2012-07-25
K121557	Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	LDJ	Class II	2012-07-25
K121510	Idrive Ultra Powered Handle Endo Gia Adapter	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2012-07-25
K121275	Aquacel Ag Extra Hydrofiber Dressing with Silver and Strengthening Fiber	ConvaTec Limited	FRO	Unclassified	2012-07-25
K121252	Hoffmann 3 Modular External Fixation System	Stryker Corp.	KTT	Class II	2012-07-25
K121195	Nvision Vle Imaging System Nvision Vle Catheter	Ninepoint Medical, Inc.	NQQ	Class II	2012-07-25
K121134	Tl Triseb Cream	Trigen Laboratories, Inc.	FRO	Unclassified	2012-07-25
K120988	Dlp Single Stage Venous Cannula, Dlp Right Angle Single Stage Venous Cannula, Dlp Single Stage Venous Cannula with Right	Medtronic, Inc.	DWF	Class II	2012-07-25
K120958	Posisep and Posisep X Hemostat Dressings	Hemostasis, LLC	QSY	Unclassified	2012-07-25
K120914	Flexitime Fast & Scan Light Flow	Kulzer GmbH	ELW	Class II	2012-07-25
K120625	Elecsys Hsv-1 Igg Immunoassay Elecsys Precicontrol Hsv	Roche Diagnostics GmbH	MXJ	Class II	2012-07-25
K120377	Adverl Evo Er: Yag Laser for Dentistry Mey-1-a	J. Morita USA, Inc.	GEX	Class II	2012-07-25
K120262	Hls Uni Evolution & U-Kneetec	TORNIER Inc.	HSX	Class II	2012-07-25
K120176	Senzzzzz Away	Centrix, Inc.	LBH	Class II	2012-07-25
K111465	Compothixo	Kerrhawe SA	DZN	Class I	2012-07-25
K121912	E1 Ear Sensors	Masimo Corporation	DQA	Class II	2012-07-24
K121759	Cone-Trol Liquid Chemistry Controls	Cone Bioproducts	JJY	Class I	2012-07-24
K121376	Compression Care Flight	Medical Minds, LLC	JOW	Class II	2012-07-24
K121282	Microlux/dl Microlux/blu Bio/screen	Addent, Inc.	NXV	Class II	2012-07-24
K120566	O2pak Oxygen Generator	Pacific Precision Products	CAW	Class II	2012-07-24