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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 550 of 3529

510(k) clearances, page 550 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172860	Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2018-01-02
K171529	Snorer's Friend	Scope Healthcare Technologies Pty, Ltd.	LRK	Class II	2018-01-02
K163712	Clover 50/Clover60/Clover70 Diagnostic Ultrasound System	Shenzhen Wisonic Medical Technology Co., Ltd.	IYN	Class II	2018-01-02
K173664	Medtronic O-arm O2 Imaging System	Medtronic, Inc.	OWB	Class II	2017-12-29
K173403	GEM Premier 5000	Instrumentation Laboratory Co.	CHL	Class II	2017-12-29
K173102	Reliance Cervical IBF System	Reliance Medical Systems, LLC	ODP	Class II	2017-12-29
K172474	Celerity 20 HP Biological Indicator	STERIS Corporation	FRC	Class II	2017-12-29
K172357	Disposable Powder Free Vinyl Exam Glove, Clear/Yellow	Ever Growth (Vietnam) Co., Ltd.	LYZ	Class I	2017-12-29
K171737	Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves	Ansell Healthcare Products LLC	LZA	Class I	2017-12-29
K171573	Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush	Wilson-Cook Medical Inc.	FDX	Class II	2017-12-29
K171108	AUTOBAHN Nailing System	Globus Medical, Inc.	HSB	Class II	2017-12-29
K170165	Osteo-P Bone Graft Substitute	Molecular Matrix	MQV	Class II	2017-12-29
K173652	Piccolo Composite Nailing System	CarboFix Orthopedics Inc.	HSB	Class II	2017-12-28
K173087	UroLift System (UL400 and UL500)	Neotract Inc	PEW	Class II	2017-12-28
K172505	MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments	MIS Implants Technologies Ltd.	DZE	Class II	2017-12-28
K171269	X-PSI Knee System	Orthosoft Inc (D/B/A Zimmer Cas)	JWH	Class II	2017-12-28
K171061	MRSASelect II	Bio-Rad	JSO	Class II	2017-12-28
K163328	Planmed Clarity	Planmed Oy	MUE	Class II	2017-12-28
DEN160037	dermaPACE System	Sanuwave, Inc.	PZL	Class II	2017-12-28
K173420	Radiomics App v1.0	Microsoft Corp.	LLZ	Class II	2017-12-27
K172848	MEVION S250i Proton Beam Radiation Therapy Device	Mevion Medical Systems, Inc.	LHN	Class II	2017-12-27
K171037	PoreStar Patient Specific Implant	Anatomics Pty, Ltd.	JOF	Class II	2017-12-27
K170104	Compact S, Compact S (LED)	Dmetec.Co., Ltd.	ELC	Class II	2017-12-27
K173073	AltiVate Anatomic to Reverse Conversion Module	Encore Medical, LP	PHX	Class II	2017-12-26
K173008	Scs 17-01	Anika Therapeutics, Inc.	MQV	Class II	2017-12-26
K172904	IntelliVue Capnography Extension, IntelliVue Microstream Extension	Philips Medizin Systeme Boeblingen GmbH	CCK	Class II	2017-12-26
K172645	iLux Instrument, iLux Disposable	Tear Film Innovations, Inc.	ORZ	Class II	2017-12-26
K171049	Real Time Image Gating System for Proton Beam Therapy Systems	Hitachi, Ltd. Healthcare	LHN	Class II	2017-12-26
K170138	Neuronaute	Bioserenity	GWQ	Class II	2017-12-26
K170960	CoaguChek Vantus System	Roche Diagnostics GmbH	GJS	Class II	2017-12-25
K173492	MRDx BCR-ABL Test, MRDx BCR-ABL Test Software	Molecularmd Corporation	OYX	Class II	2017-12-22
K172978	SurgeoBite	Surgovations, LLC	JXL	Class II	2017-12-22
K172785	Conquest Fn	Smith & Nephew, Inc.	JDO	Class II	2017-12-22
K172706	GammaPod - Model A	Xcision Medical Systems, LLC	IWB	Class II	2017-12-22
K172688	Align Radial Head System	Skeletal Dynamics, Inc	KWI	Class II	2017-12-22
K172507	Sozo	Impedimed, Inc.	DSB	Class II	2017-12-22
K172388	Vpod Itpr	Advanced Circulatory System, A Wholly Owned Subsidiary of	BWF	Class II	2017-12-22
K172383	Arthrosurface Bone Screws	Arthrosurface, Inc.	HWC	Class II	2017-12-22
K172257	TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)	True Diagnostics, Inc.	JHI	Class II	2017-12-22
K171584	B. Braun Tear-Away Introducer Needle	B.Braun Medical, Inc.	BSO	Class II	2017-12-22
K171581	Neuro Omega System	Alpha Omega Engineering Ltd.	GZL	Class II	2017-12-22
K170993	QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer	Inova Diagnostics, Inc.	NXO	Class II	2017-12-22
DEN160014	remOVE System	Ovesco Endoscopy AG	QAG	Class II	2017-12-22
K173375	Anterior Cervical Plate System	Evolution Spine, LLC	KWQ	Class II	2017-12-21
K173332	OMNI Surgical System	Sight Sciences, Inc.	MRH	Class II	2017-12-21
K173287	Elite HV Radial	Galt Medical Corp	DYB	Class II	2017-12-21
K173250	Solana GBS Assay	Ortho-Clinical Diagnostics, Inc.	NJR	Class I	2017-12-21
K172973	Life Spine Foot and Ankle Plating System	Life Spine	HRS	Class II	2017-12-21
K172960	easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use	Ezisurg Medical Co., Ltd.	GDW	Class II	2017-12-21
K172926	SeaSpine Vu cPOD, Zuma-C, Complete Cervical	SeaSpine Orthopedics Corporation	ODP	Class II	2017-12-21