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 2026-11-02, 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 946 of 3531

510(k) clearances, page 946 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K112409	Matristem Wound Matrix	ACell, Inc	KGN	Unclassified	2011-08-29
K112341	Snap Wound Care System	Spiracur, Inc.	OKO	Class II	2011-08-29
K112339	Accuvix A30 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2011-08-29
K111608	Slic Screw Repair System	Acumed LLC	HWC	Class II	2011-08-29
K111572	Novae Sunfit Th Dual Mobility Acetabular Cup Model Sunfit Th (Metal-Back), Novae E Th Dual Mobility Acetabular Cup Model	Serf	LZO	Class II	2011-08-29
K111386	Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (Pss)	Abbott Medical	FRN	Class II	2011-08-29
K111374	Sono-Series Cornerstone Technique	Pajunk GmbH Medizintechnologie	BSP	Class II	2011-08-29
K111172	4 Series Phototherapy Unit Model 4 Series	The Daavlin Distributing Co.	FTC	Class II	2011-08-29
K110756	Bluephase Style	Ivoclar Vivadent, Inc.	EBZ	Class II	2011-08-29
K110648	Nova Stat Profile Phox Ultra Analyzer System	Nova Biomedical Corporation	CHL	Class II	2011-08-29
K103799	Inqu Paste Mix Plus	Isto Technologies, Inc.	MQV	Class II	2011-08-29
K103308	Aida Hd Connect with Smartscreen / Blu-Ray Drive / Smartscreen with Blu-Ray Drive	Karl Storz Endoscopy-America, Inc.	LLZ	Class II	2011-08-29
K091960	Vysis Egr1 Fish Probe Kit (Vysis Lsi Egr1 Spectrum/orange/d5s23, D5s721, Spectrum Green Probe), Model 4N37-020	Abbott Molecular, Inc.	OWK	Class II	2011-08-29
K083577	Harmonie System	Stellate Systems	GWQ	Class II	2011-08-29
K112235	Airstrip Remote Patient Monitoring (Rpm) Remote Data Viewing	AirStrip Technologies, Inc.	MWI	Class II	2011-08-26
K112182	Angiosculpt Pta Scoring Balloon Catheter	Spectranetics Corp.	PNO	Class II	2011-08-26
K112137	Comfortglide Intermitent Catheter	C.R. Bard Inc	EZD	Class II	2011-08-26
K111573	Monobloc Bm Series	Hass Corp.	EIH	Class II	2011-08-26
K111535	Emm Surgical Gown - Spunlace with Pe Layer	Exact Medical Manufacturing, Inc.	FYA	Class II	2011-08-26
K111301	Instinct Java System	Zimmer Spine, Inc.	NKB	Class II	2011-08-26
K110451	Endowrist One Suction/irrigator	Intuitive Surgical, Inc.	NAY	Class II	2011-08-26
K110269	Well Lead Endotracheal Tube with Evacuation Lumen-Oral	Well Lead Medical Co. Ltd	BTR	Class II	2011-08-26
K103532	Autoreader 2	Trek Diagnostic Systems, Ltd.	LRG	Class II	2011-08-26
K103181	Zenis, Picture Archiving and Communications System	Genoray Co., Ltd.	LLZ	Class II	2011-08-26
K103087	Covamax Resorbable Collagen Membrane	Biom'Up SAS	NPL	Class II	2011-08-26
K102678	Andon Health Care Management System Software, Ag-608 Single & Ag-608 Multi Blood Glucose Monitoring Systems	Andon Medical co., Ltd	NBW	Class II	2011-08-26
K112112	Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems	Sentinel Medical, Inc.	MOS	Class II	2011-08-25
K112104	Elecsys N-Mid Osteocalcin Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-08-25
K111633	Aquilion Lb Movement Base Kit	Toshiba America Medical Systems, In.C	JAK	Class II	2011-08-25
K111592	Youlaser CO2 Laser System	Quanta System Inc.	GEX	Class II	2011-08-25
K111584	Xylos Macro-Porous Surgical Mesh	Xylos Corporation	FTM	Class II	2011-08-25
K111482	Sonicator Plus 920	Mettler Electronics Corp	IMG	Class II	2011-08-25
K111101	Norport CT-Pc, Lucent Non-Coring Needel Infusion Set	Norfolk Medical	LJT	Class II	2011-08-25
K110977	Vesoflow	Caremed Supply, Inc.	JOW	Class II	2011-08-25
K110934	Advia Chemistry Hemoglobin A1c_3 (A1c_3) Automated Pretreatment Assay	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2011-08-25
K110733	Daytona Anterior Cervical Cage	SpineNet LLC	ODP	Class II	2011-08-25
K102926	Gemore Muscle Conditioner;	Gemore Technology Co., Ltd.	NGX	Class II	2011-08-25
K101234	Ventana Anti-Helicobacter Pylori (Sp48) Rabbit Monoclonal Primary Antibody	Ventana Medical Systems Inc	OWF	Class I	2011-08-25
K112089	Biogel Orthopor Brown Surgical Glove	Molnlycke Health Care, US LLC	KGO	Class I	2011-08-24
K111917	Nuvant, Mobile Cardiac Telemetry	Corventis, Inc.	QYX	Class II	2011-08-24
K111805	ECG Series Electrocardiograph	Advanced Instrumentations, Inc.	DPS	Class II	2011-08-24
K111528	Pioneer Aspect Anterior Cervical Plate Model 24-Series	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	Class II	2011-08-24
K111525	Perimeter Interbody Fusion Device	Medtronic Sofamor Danek	MAX	Class II	2011-08-24
K111439	Chesapeake (Cervical Components)	K2M, Inc	OVE	Class II	2011-08-24
K111293	Soundcure Serenade Tinnitus Treatment System	Soundcure, Inc.	KLW	Class II	2011-08-24
K110776	Digital Thermometer Mt Series	Sejoy Electronics & Instruments Co., Ltd.	FLL	Class II	2011-08-24
K110621	Shengkun Chemical	Zibo Shengkun Chemical Industrial Co., Ltd.	LYZ	Class I	2011-08-24
K110031	Hemosil Drvvt Screen & Hemosil Drvvt Confirm	Instrumentation Laboratory Co.	GIR	Class I	2011-08-24
K103719	Lifecare Conductive Garments	Everyway Medical Instruments Co., Ltd.	GXY	Class II	2011-08-24
K103706	The Core (Cardiac Outpatient Realtime ECG) Monitor	Applied Cardiac Systems	QYX	Class II	2011-08-24