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 587 of 3529

510(k) clearances, page 587 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K170250	SmartTarget	Smarttarget, Ltd.	LLZ	Class II	2017-06-07
K170144	StentBoost Live	Philips Medical Stystems Nederland BV	OWB	Class II	2017-06-07
K163679	Digital Automatic Blood Pressure Monitor MD3600	Grandway Technology (Shenzhen) Limited	DXN	Class II	2017-06-07
K163531	Advanced Perfusion System 1	Terumo Cardiovascular Systems Corporation	DTQ	Class II	2017-06-07
K163357	OneTouch Via On-Demand Insulin Delivery System	Lifescan Europe, A Division of Cilag GmbH	OPP	Class II	2017-06-07
K162564	Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System	Tianjin Empecs Medical Device Co., Ltd.	NBW	Class II	2017-06-07
K162109	Kwart Retro-Inject Ureteral Stent	Cook Incorporated	FAD	Class II	2017-06-07
K160673	Insulin Algorithms System	Insulin Algorithms	NDC	Class II	2017-06-07
K171429	Magnetic Surgical System	Levita Magnetics International Corp.	PNL	Class II	2017-06-06
K171347	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection	Xeridiem Medical Devices	PIF	Class II	2017-06-06
K170709	CURVE Laser System	Yolo Medical, Inc.	OLI	Class II	2017-06-06
K170687	Flower Bone Screw Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HWC	Class II	2017-06-06
K170591	Altomed Malhotra Platinum Segments	Altomed Ltd.	MML	Class II	2017-06-06
K170374	SonoBook Series Diagnostic Ultrasound System	Chison Medical Imaging Co., Ltd.	IYN	Class II	2017-06-06
K170155	EK12 Algorithm	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2017-06-06
K170044	Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System	Prismatik Dentalcraft, Inc.	NHA	Class II	2017-06-06
K163603	Digital Thermometer	Guangzhou Jinxinbao Electronic Co., Ltd.	FLL	Class II	2017-06-06
K162372	QT Ultrasound Breast Scanner-1	Qt Ultrasound, LLC	IYO	Class II	2017-06-06
K161420	Moves Slc	Thornhill Research Inc	BTL	Class II	2017-06-06
K171013	Revolution ACT	GE Hangwei Medical Systems, Co. Ltd	JAK	Class II	2017-06-05
K170441	ElectroTek	Mobilemedtek	GWQ	Class II	2017-06-05
K163334	LiDCOunity v2 Hemodynamic Monitor	Lidco Ltd	DXG	Class II	2017-06-05
K163228	APVolution System	Aesthetic-Press, LLC	EIH	Class II	2017-06-05
K171438	Palisade™ Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2017-06-02
K171308	Tubing Pack	Medtronic, Inc.	DWF	Class II	2017-06-02
K171157	PolyDev Soft Contact Lenses	Polydev, Ltd.	LPL	Class II	2017-06-02
K171101	Closed Male Luer	Yukon Medical, LLC	FPA	Class II	2017-06-02
K171060	OrthoButton AL	Riverpoint Medical, LLC	MBI	Class II	2017-06-02
K170995	Electrocardiograph	Edan Instruments, Inc.	DPS	Class II	2017-06-02
K170973	VitalWatch Software User Interface	VitalConnect, Inc.	DRG	Class II	2017-06-02
K170890	TELIX K Interbody System	BIEDERMANN MOTECH GmbH & Co. KG	MAX	Class II	2017-06-02
K170877	Parcus SLiK Fix Screw	Parcus Medical, L.L.C.	MBI	Class II	2017-06-02
K170726	Biopsy Forceps	Fehling Instruments GmbH & Co. KG	DWZ	Class II	2017-06-02
K170655	Zepto	Mynosys Cellular Devices, Inc.	PUL	Class II	2017-06-02
K170395	Talos® Lumbar (HA) PEEK IBF Devices	Meditech Spine, LLC	MAX	Class II	2017-06-02
K170311	Reprocessed Agilis NxT Steerable Introducer	Innovative Health, LLC.	PNE	Class II	2017-06-02
K170130	Dynamic Coronary Roadmap	Philips Medical Systems Nederland B.V.	OWB	Class II	2017-06-02
K170026	Radiopaque Tissue Marker	Viscus Biologics, LLC.	NEU	Class II	2017-06-02
K170001	Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2017-06-02
K163639	LS-5 ePTFE Suture	Lsi Solutions Inc.	NBY	Class II	2017-06-02
K163585	Responsive Orthopedics Total Hip Arthroplasty System	Responsive Orthopedics, LLC	LZO	Class II	2017-06-02
K163512	Zio AT ECG Monitoring System	iRhythm Technologies, Inc.	QYX	Class II	2017-06-02
K163470	Galvanic Spa, Model: SKB-1405	Shenzhen Siken 3D Technology Development Co., Ltd.	NFO	Class II	2017-06-02
K162759	KeraStat(R) Gel	Keranetics, Inc.	KGN	Unclassified	2017-06-02
K162681	Enobio Wireless EEG	Neuroelectrics Barcelona S.L.U.	GWQ	Class II	2017-06-02
K162395	MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup	Mp Biomedicals, LLC	DIO	Class II	2017-06-02
K171344	Xenocor Xenoscope Laparoscopic System	Xenocor, Inc.	GCJ	Class II	2017-06-01
K171053	syngo Dynamics Version VA30	Siemens Healthcare GmbH	LLZ	Class II	2017-06-01
K170904	Biograph Horizon PET/CT	Siemens Medical Solutions USA, Inc.	KPS	Class II	2017-06-01
K170741	GTK Disposable Needle Guides	Geotek Medikal Ltd Sti	ITX	Class II	2017-06-01