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 792 of 3530

510(k) clearances, page 792 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131033	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Decent Plastic Co., Ltd.	LYZ	Class I	2014-02-12
K130930	Owl Contact Lens Cases, Dog Contact Lens Cases	Ningbo Lishunda Electronics Co., Ltd.	LRX	Class II	2014-02-12
K130040	Mepitel Ag	Molnlycke Health Care	FRO	Unclassified	2014-02-12
K123537	Powder Free Latex Examination Gloves	Qube Medical Product Sdn Bhd	LYY	Class I	2014-02-12
K122758	Powerheart G5 AED	ZOLL Medical Corporation	MKJ	Class III	2014-02-12
K140117	Ahbppress Absorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2014-02-11
K140063	Equinoxe Extra Short Humeral Head	Exactech, Inc.	KWS	Class II	2014-02-11
K133607	V8 Transluminal Bav Catheter	Intervalve, Inc.	OZT	Class II	2014-02-11
K133359	Endorings	Endo-Aid, Inc.	FED	Class II	2014-02-11
K133318	Adhese Universal	Ivoclar Vivadent, Inc.	KLE	Class II	2014-02-11
K133267	Dana Reusable Test Pack	Dana Products, Inc.	FRC	Class II	2014-02-11
K132925	Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T, Low-Top, Savannah-Link	Spinal Elements, Inc	NKB	Class II	2014-02-11
K132583	Ez-Io Intraosseous Infusion System	Teleflex Medical	FMI	Class II	2014-02-11
K132472	Justright 5Mm Stapler, Justright 5Mm Reload	Bolder Surgical, LLC	GDW	Class II	2014-02-11
K130485	Control Seal	Voco GmbH	EBC	Class II	2014-02-11
K122632	Guava II	Cardiocomm Solutions, Inc.	DPS	Class II	2014-02-11
K133692	Imri 1.5T and Imri 3T S	Imris, Inc.	LNH	Class II	2014-02-10
K133623	C-Plus	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	ODP	Class II	2014-02-10
K133583	Opticage Interbody Fusion Device, Model Series 9070	Interventional Spine, Inc.	MAX	Class II	2014-02-10
K133497	Aquilion One Vision	Toshibamedical Systems Corporation	JAK	Class II	2014-02-10
K133477	Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis	Synchro Medical	HTY	Class II	2014-02-10
K131146	Artassist and Venassist	Aci Medical, LLC	JOW	Class II	2014-02-10
K130991	Nexxzr(tm)t and Nexxzr(tm)s	Sagemax Bioceramics, Inc.	EIH	Class II	2014-02-10
K130511	Citrisol Acid Concentrate	Diasol, Inc	KPO	Class II	2014-02-10
K133552	Magellan Robotic Catheter 6Fr (Guide and Leader), Magellan Robotic Catheter 6Fr Accessory Kit	Hansen Medical, Inc.	DRA	Class II	2014-02-07
K133462	Duocentric Reversed Shoulder Prosthesis	Aston Medical	KWS	Class II	2014-02-07
K133263	Proteus Patch, Proteus Ingestible Sensor (Accessory)	Proteus Digital Health, Inc.	OZW	Class II	2014-02-07
K133247	Eclipse Treatment Planning System	Varian Medical Systems, Inc.	MUJ	Class II	2014-02-07
K132650	Sonicaid Freedom Wireless Fetal Monitoring System	Huntleigh Healthcare Ltd.	HGM	Class II	2014-02-07
K132539	Ring-Lok Modular Bipolar System	Implants International, Ltd.	KWY	Class II	2014-02-07
K132050	Nb3d Bone Void Filler	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MQV	Class II	2014-02-07
K131966	Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System	Twin Star Medical, Inc.	LXC	Unclassified	2014-02-07
K130807	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Hope Plastic Co., Ltd.	LYZ	Class I	2014-02-07
K130723	Fdes106 Mini Tens&ems Device,fdes106 Multi-Function Mini Tens&ems Device,fdes105 Pain Relief Plaster,fdes107 Abdominal	Famidoc Technology Co., Ltd	NGX	Class II	2014-02-07
K130616	Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-Needles	Biopsybell S.r.l.	KNW	Class II	2014-02-07
K130401	Alertwatch: or	Alertwatch, Inc.	MHX	Class II	2014-02-07
K123880	Quanta Flash Centromere	Inova Diagnostics, Inc.	LJM	Class II	2014-02-07
K140036	Aptus Heli-Fx Guide - 22Cm Deflectable Length; Aptus Heli-Fx Guide - 28Cm Deflectable Length; Aptus Heli-Fx Applier with	Aptus Endosystems, Inc.	OTD	Class II	2014-02-06
K133701	Nuvant Mct System	Corventis, Inc.	QYX	Class II	2014-02-06
K133523	Stapix Superelastic Implant Bone Staples	Instratek, Inc.	JDR	Class II	2014-02-06
K133396	Vdrive with V-Sono	Stereotaxis Inc	DQX	Class II	2014-02-06
K133394	Airstrip Remote Patient Monitoring	AirStrip Technologies, Inc.	MWI	Class II	2014-02-06
K132839	Fuse 1C Colonoscopy System	Boston Scientific Corporation	FDF	Class II	2014-02-06
K132824	Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application	Eastman Kodak Company	LLZ	Class II	2014-02-06
K132813	Dual Energy System Package	Toshibamedical Systems Corporation	JAK	Class II	2014-02-06
K131341	Powder Free Yellow Synthetic Vinyl Patient Examination Gloves	Shijiazhuang Winful Plastic Co., Ltd.	LYZ	Class I	2014-02-06
K130921	Alivecor Heart Monitor OTC	AliveCor	DPS	Class II	2014-02-06
K130890	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Air Plastic Co., Ltd.	LYZ	Class I	2014-02-06
K130864	C-Max+ (Plus)	AAT Alber Antriebstechnik GmbH	ILK	Class II	2014-02-06
K130249	Integrity Spinal Care System 3.0	Integrity Life Sciences	ITH	Class II	2014-02-06