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 633 of 3529

510(k) clearances, page 633 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161347	Signia sterilization tray	Medtronic, Inc.	KCT	Class II	2016-09-07
K161165	Next Science Irrigation Solution	Next Science, LLC	FQH	Class II	2016-09-07
K160783	Procellera	Vomaris Innovations, Inc.	FRO	Unclassified	2016-09-07
K160724	ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator	Siemens Healthcare Diagnostics Inc.	CGS	Class II	2016-09-07
K160575	CareSens Pen Needle, Softip Pen Needle	Yidobio, Inc.	FMI	Class II	2016-09-07
K153644	ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II	ELITechGroup Inc	CFR	Class II	2016-09-07
K153580	Central Monitoring System	Guangdong Biolight Meditech Co., Ltd	HGM	Class II	2016-09-07
K153542	Pelican Sling Retractor	Beacon Surgical, Inc.	GCJ	Class II	2016-09-07
K153207	Additive Orthopaedics Bone Wedge System	Additive Orthopaedics, LLC	HRS	Class II	2016-09-07
K162267	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2016-09-06
K162243	ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System	Siemens Medi Cal Solutions, Inc.	IYN	Class II	2016-09-06
K162221	ACUSON SC2000 Diagnostic Ultrasound System	Siemens Medical Solutions Inc. Ultrasound Group	IYN	Class II	2016-09-06
K161765	CG+ Arrow JACC	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	LJS	Class II	2016-09-06
K161600	Resection Electrodes	Olympus Winter & Ibe GmbH	JOS	Class II	2016-09-06
K161585	Mano and Mano Personal Lubricant	Mano and Mano Proprietary Limited	NUC	Class II	2016-09-06
K161485	Nanovis Intervertebral Body Fusion System and Forticore(R)	Nanovis, LLC	MAX	Class II	2016-09-06
K161478	Xenco Medical Posterior Cervical System	Xenco Medical LLC	NKG	Class II	2016-09-06
K161459	Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)	Varian Medical Systems, X-Ray Products-Infimed	MQB	Class II	2016-09-06
K160709	HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves	Halyard Health	LZC	Class I	2016-09-06
K160269	Surgical Face Masks (Ear loops and Tie-on)	San-M Package Co., Ltd.	FXX	Class II	2016-09-06
K160159	Active-X Total Knee System	Signature Orthopaedics Pty Limited	JWH	Class II	2016-09-06
K153046	Hamilton-Mr1	Hamilton Medical AG	CBK	Class II	2016-09-06
K151589	Bd Max Ct/gc/tv, Bd Max Instrument	Becton Dickinson & Co	OUY	Class II	2016-09-06
K151455	3Shape Abutment Designer Software	3Shape A/S	PNP	Class II	2016-09-06
K161756	SyncVision System	Volcano Corporation	OWB	Class II	2016-09-05
K161465	CardioConfirm	Mortara Instrument, Inc.	DQK	Class II	2016-09-03
K162184	Edwards eSheath Introducer Set	Edwards Lifesciences LLC	DYB	Class II	2016-09-02
K162141	Restore PACS	Xian Wingspan Electronic Technology Co., Ltd.	LLZ	Class II	2016-09-02
K161751	MAGEC® Spinal Bracing and Distraction System	NuVasive Specialized Orthopedics, Inc.	PGN	Class II	2016-09-02
K161602	Arctic Sun Temperature Management System	Medivance Inc.	DWJ	Class II	2016-09-02
K161573	FilmArray RP EZ Control Panel M265	Maine Molecular Quality Controls, Inc.	PMN	Class II	2016-09-02
K161524	Tangis Anterior Cervical Plate	Nvision Biomedical Technologies, Inc	KWQ	Class II	2016-09-02
K161317	Sysmex Automated Blood Coagulation Analyzer CS-5100	Siemens Healthcare Diagnostics Products Limited	JPA	Class II	2016-09-02
K161168	MyLabSix Ultrasound System	Esaote Europe B.V.	IYN	Class II	2016-09-02
K160698	LigaPASS	Medicrea International	OWI	Class II	2016-09-02
K160593	Indy OTW Vascular Retriever	Cook Incorporated	MMX	Class II	2016-09-02
K160582	WiCap	Athena GTX	DQA	Class II	2016-09-02
K160423	Perineologic Access Needle	Corbin Clinical Resources, LLC	FCG	Class II	2016-09-02
K160066	Pro-Link® Stand-Alone Cervical Spacer System	Life Spine	OVE	Class II	2016-09-02
K153707	Nihon Kohden Vital Sign Telemeter	Nihon Kohden Corp.	MHX	Class II	2016-09-02
K153705	PROcedure Rehearsal Studio	3Dsystems, Simbionix Products	LLZ	Class II	2016-09-02
K152981	Jet Set 4 Denture Repair Resin	Lang Dental Manufacturing Co., Inc.	EBI	Class II	2016-09-02
DEN150049	Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm	Concentric Medical, Inc.	POL	Class II	2016-09-02
K162178	CareView 1500P X-ray Flat Panel Detectors	Careray Digital Medical System Co., Ltd.	MQB	Class II	2016-09-01
K161963	Monoject Enteral Syringe with ENFit Connector	Medtronic, Inc.	PNR	Class II	2016-09-01
K161942	PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector	Revvity Health Sciences, Inc.	MQB	Class II	2016-09-01
K161922	Xp202	3M Deutschland GmbH	EIH	Class II	2016-09-01
K161707	Madsen Zodiac	Natus Medical Denmark ApS	ETY	Class II	2016-09-01
K161656	Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor	Ambu A/S	EOQ	Class II	2016-09-01
K161567	SIGNA Voyager	GE Healthcare	LNH	Class II	2016-09-01