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 661 of 3529

510(k) clearances, page 661 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152707	Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color	Minghao Medical Products Co., Ltd.	LZA	Class I	2016-03-17
K152705	Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color	Jiayuan Medical Products Co., Ltd.	LZA	Class I	2016-03-17
K152699	Apollo System	Penumbra Inc.	GWG	Class II	2016-03-17
K152686	Conquest Fn	Smith & Nephew, Inc.	JDO	Class II	2016-03-17
K152598	Endo Keeper	Nelis	OTJ	Class II	2016-03-17
K152334	Sungshim Insulin Pen Needle	Sung Shim Medicare Co., Ltd.	FMI	Class II	2016-03-17
K151706	Specular Microscope CEM- 530	Nidek Co., Ltd.	NQE	Class II	2016-03-17
K151689	MetaNeb 4 System	Hill-Rom Services Pte, Ltd.	NHJ	Class II	2016-03-17
K160445	HemosIL Silica Clotting Time	Instrumentation Laboratory Co.	GFO	Class II	2016-03-16
K160406	FUJIFILM FC1 Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2016-03-16
K160150	Vitrea CT Colon Analysis	Canon Medical Informatics, Inc.	LLZ	Class II	2016-03-16
K153613	Cerafix Dura Substitute	Acera Surgical, Inc. C/O Linda Braddon, PhD	GXQ	Class II	2016-03-16
K153519	DReal	Carevature Medical, Ltd.	HBE	Class II	2016-03-16
K153355	Xeleris 4.0 Processing and Review Workstation	GE Healthcare	LLZ	Class II	2016-03-16
K153250	Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System	Renovis Surgical Technologies, LLC	OVE	Class II	2016-03-16
K152093	NobelZygoma 45°	Nobel Biocare AB	DZE	Class II	2016-03-16
K151665	SUSTAIN Additional Implants	Globus Medical, Inc.	MAX	Class II	2016-03-16
K151268	Spinaut-V, Spinaut-S, Spinaut-I	Imedicom Co., Ltd.	HRX	Class II	2016-03-16
K160457	FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch	BioFire Diagnostics, LLC	PEN	Class II	2016-03-15
K160409	AOS Anterolateral Proximal Humeral Plate	Advanced Orthopaedic Solutions, Inc.	KTW	Class II	2016-03-15
K160114	Xspan Laminoplasty Fixation System	Xtant Medical Holdings, Inc.	NQW	Class II	2016-03-15
K153633	Endoform Reconstructive Template	Aroa Biosurgery Limited (Formerly Mesynthes Limited)	FTM	Class II	2016-03-15
K153612	ArthrexVIP Web Portal	Custom Orthopaedic Solutions, Inc.	LLZ	Class II	2016-03-15
K153584	NeoTract UroLift System UL500	Neotract Inc	PEW	Class II	2016-03-15
K153335	AlertWatch: OR	Alertwatch, Inc.	MWI	Class II	2016-03-15
K153238	Dignity Dual Port	Medcomp ( Medical Components)	LJT	Class II	2016-03-15
K151763	PerioLase Nd:YAG Pulsed Dental Laser System	Millennium Dental Technologies, Inc.	GEX	Class II	2016-03-15
K151135	Model 621/624 Biomagnetometer	Tristan Technologies, Inc.	DPS	Class II	2016-03-15
K153754	MicroMatrix	ACell, Inc	KGN	Unclassified	2016-03-14
K153661	ImmunoCard STAT! HpSA	Meridian Bioscience Inc	LYR	Class I	2016-03-14
K153412	Sleep Profiler	Advanced Brain Monitoring, Inc.	OLZ	Class II	2016-03-14
K153153	Reprocessed Electrophysiology Catheter	Innovative Health, LLC.	NLH	Class II	2016-03-14
K153119	Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,	Summit Industries, LLC	KPR	Class II	2016-03-14
K153041	Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling	Integra LifeSciences Corporation	JXG	Class II	2016-03-14
K153027	Cryotop US	Kitazato Biopharma Co., Ltd.	MQK	Class II	2016-03-14
K152845	Allied Biocompat Abutment for Nobel Replace Interface	Allied Dental Solutions	NHA	Class II	2016-03-14
K152530	UCP Stem	United Orthopedic Corp.	LZO	Class II	2016-03-14
K160145	Full Automatic (NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2016-03-13
K160662	Surefire Infusion System	Surefire Medical, Inc.	DQO	Class II	2016-03-11
K160389	NovaCross Microcatheter	Nitiloop, Ltd.	DQY	Class II	2016-03-11
K160374	20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System	Tangent Medical Technologies, Inc.	FOZ	Class II	2016-03-11
K160064	MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System	Infobionic, Inc.	QYX	Class II	2016-03-11
K152646	Sylk Personal Lubricant	Toro Management, LLC dba Sylk	NUC	Class II	2016-03-11
K152394	Rapicide PA High-Level Disinfectant Test Strips	Medivators Inc	JOJ	Class II	2016-03-11
K152178	StimQ Peripheral Nerve Stimulator (PNS) System	Stimq, LLC	GZF	Class II	2016-03-11
K151965	Dentti System	Martz, Inc.	NXC	Class II	2016-03-11
K151780	CAAS Workstation	PIE Medical Imaging B.V.	IZI	Class II	2016-03-11
K151748	Clean & More	3M Deutschland GmbH	PIP	Class II	2016-03-11
K151688	chromID MRSA	bioMerieux, Inc.	JSO	Class II	2016-03-11
K151559	ImmuLisa Enhanced Centromere Antibody ELISA	Immco Diagnostics, Inc.	LJM	Class II	2016-03-11