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 805 of 3530

510(k) clearances, page 805 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132526	Knit-Pak+	Premier Dental Products Co	MVL	Unclassified	2013-11-26
K132372	Steritec Green Card Pack Bowie-Dick Test	Steritec Products Mfg. Co., Inc.	JOJ	Class II	2013-11-26
K132170	Shaser V-Mini Rx	Shaser, Inc.	ONF	Class II	2013-11-26
K131998	Aspire Rx-Lp6 Aspiration Catheter	Control Medical Technology	QEZ	Class II	2013-11-26
K131997	Newtron Booster	Satelec-Acteon Group	ELC	Class II	2013-11-26
K131913	Intellivue Cl Spo2 Pod and Cl Nbp Pod, Philips Intellivue Patient Monitors Mp5, Mp5t, Mp5sc	Philips Medizin Systeme Boeblingen GmbH	DRG	Class II	2013-11-26
K131897	Cv3000 Holter Analysis System	Vales & Hills Biomedical Tech., Ltd.	MLO	Class II	2013-11-26
K131828	Powder Free Vinyl Patient Examination Glvoes, Light Yellow Color	Jiangsu Handsafe Glove Co., Ltd.	LYZ	Class I	2013-11-26
K131699	Emotion ECG Mobile	Mega Electronics, Ltd.	DXH	Class II	2013-11-26
K131646	Disposable Infusion Set	Shanghai Jinta Medical Co., Ltd.	LHI	Class II	2013-11-26
K131629	Neurodyn Multiwave, Aussie Sport	Ibramed Equipamentos Medicos	IPF	Class II	2013-11-26
K131369	Flexible Video-Uretero-Renoscope System	Karl Storz Endoscopy-America, Inc.	FGB	Class II	2013-11-26
K131302	Solax	Dongguan Prestige Sporting Goods Co., Ltd.	INI	Class II	2013-11-26
K131298	Exactech Equinoxe Resurfacing Humeral Head System	Exactech, Inc.	HSD	Class II	2013-11-26
K122340	Prodigy Choice	Prodigy Diabetes Care, LLC	NBW	Class II	2013-11-26
K122024	Spsmedical Sporview 10 Steam Self Contained Biological Indicator	Spsmedical Supply Corp.	FRC	Class II	2013-11-26
K133357	Charruapacs System	Charruasoft SA	LLZ	Class II	2013-11-25
K132884	Pathfinder Nxt Minimally Invasive Pedicle Screw System	Zimmer Spine, Inc.	NKB	Class II	2013-11-25
K132639	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2013-11-25
K132597	Black Coloured Condom	Karex Industries Sdn Bhd	HIS	Class II	2013-11-25
K132544	Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-Arena	TOMTEC Imaging Systems GmbH	LLZ	Class II	2013-11-25
K132509	Fdr D-Evo Flat Panel Detector System	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2013-11-25
K132504	Tiger Occipital-Cervical-Thoracic Spinal Fixation System	Corelink, LLC	KWP	Class II	2013-11-25
K132498	Valved Tearaway Introducer Generation II	Medcomp ( Medical Components)	DYB	Class II	2013-11-25
K132217	Arthrex Compression Ft Screws	Arthrex GmbH	HWC	Class II	2013-11-25
K132101	Anax 5.5 Spinal System	CG MedTech Co., Ltd.	MNH	Class II	2013-11-25
K132029	Vault-C Intervertebral Body Fusion Device	Spinal USA	OVE	Class II	2013-11-25
K131339	Capnomask	Mediplus Ltd.	CCK	Class II	2013-11-25
K130856	Bia / Vitality Analyzer	Ipgdx, LLC	MNW	Class II	2013-11-25
K130777	Inbody	Biospace Inc.	MNW	Class II	2013-11-25
K130135	Dana Reusable Bi Test Pack	Dana Products, Inc.	JOJ	Class II	2013-11-25
K133399	Diamondback 360 Peripheral Orbital Atherectomy System	Cardiovascular Systems Incorporated	MCW	Class II	2013-11-22
K133284	Elecsys Ck-Mb Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2013-11-22
K133216	Crescent Spinal System	Medtronic Sofamor Danek	MAX	Class II	2013-11-22
K133067	Advia Chemistry Triglycerides_2 (Trig_2) Reagent	Siemens Healthcare Diagnostics Inc.	CDT	Class I	2013-11-22
K132918	Sense-4Baby System	Sense4baby, Inc.	HGM	Class II	2013-11-22
K132728	V8 Transluminal Bav Catheter	Intervalve, Inc.	OZT	Class II	2013-11-22
K132588	Adhesive Electrodes	Top-Rank Health Care Equipment Co., Ltd.	GXY	Class II	2013-11-22
K132443	Piezon 150	E.M.S. - Electro Medical Systems SA	ELC	Class II	2013-11-22
K132371	Easycare Online	ResMed Corp	MNS	Class II	2013-11-22
K132288	Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood Glucose Meter	I-SENS, Inc.	NBW	Class II	2013-11-22
K132191	Sp-Fix Spinous Process Fixation Plate	Globus Medical, Inc.	PEK	Class II	2013-11-22
K132189	Otomag Bone Conducation Hearing System	Sophono, Inc.	LXB	Class II	2013-11-22
K132119	Magnetom Prisma, Magnetom Prisma Fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-11-22
K131826	Toptouch /Other Clients Private Labeling	Jiangsu Toptouch Glove Co., Ltd.	LYZ	Class I	2013-11-22
K131819	Pc ECG	Edan Instruments, Inc.	DPS	Class II	2013-11-22
K131482	Sofia Distal Access Catheter	Terumo Cardiovascular Systems Corporation	DQY	Class II	2013-11-22
K130730	V-Stick Vascular Access Set	Argon Medical Corp.	DYB	Class II	2013-11-22
K130554	Redsense Alarm System	Redsense Medical AB	ODX	Class II	2013-11-22
K130515	Virtuoso System for Ihc Er (Spi)	Ventana Medical Systems Inc	NQN	Class II	2013-11-22