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 566 of 3529

510(k) clearances, page 566 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K170079	Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System	Tyson Bioresearch, Inc.	NBW	Class II	2017-10-06
K163526	Bilicocoon™ Phototherapy System	Neomedlight	LBI	Class II	2017-10-06
K172855	Vitrea Advanced Visualization, Version 7.6	Canon Medical Informatics, Inc.	LLZ	Class II	2017-10-05
K172667	MagVita TMS Therapy w/MagPro R20	Tonica Elektronik a/S	OBP	Class II	2017-10-05
K172574	SyncVision System	Volcano Corporation	OWB	Class II	2017-10-05
K172558	iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit	Stryker Corp.	KNW	Class II	2017-10-05
K172408	Biomet Bone Cement R	Zimmer GmbH	LOD	Class II	2017-10-05
K172099	Shoocin Introducer Kit	Lepu Medical Technology (Beijing) Co., Ltd	DYB	Class II	2017-10-05
K172093	Reprocessed Covidien Trocar	ReNovo, Inc.	NLM	Class II	2017-10-05
K172089	PROLENE Soft Polypropylene Mesh	Ethicon, Inc	FTL	Class II	2017-10-05
K172059	LinkQuest Diagnostic Ultrasound System model SQ860	Linkquest, Inc.	IYN	Class II	2017-10-05
K171689	ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology	Medtronic Sofamor Danek USA Inc	MAX	Class II	2017-10-05
K171503	Reprocessed CristaCath Diagnostic Electrophysiology Catheter	Innovative Health, LLC.	NLH	Class II	2017-10-05
K171491	R2P Destination Slender Guiding Sheath	Terumo Medical Corp.	DYB	Class II	2017-10-05
K171175	Aquarius 8600 1417WC	Imaging Dynamics Company, Ltd.	MQB	Class II	2017-10-05
K170548	InSure ONE	Enterix, Inc.	KHE	Class II	2017-10-05
K170452	Medacta Shoulder System	Medacta International SA	PHX	Class II	2017-10-05
K170344	Tahoe Uni Knee System	Consensus Orthopedics, Inc.	HSX	Class II	2017-10-05
K170264	Gold AQ Blood Glucose Monitoring System	Changsha Sinocare Inc.	NBW	Class II	2017-10-05
K163366	Shanghai Sanyou CARMEN Cervical Fusion System	Shanghai Sanyou Medical Co. Ltd	KWQ	Class II	2017-10-05
K172691	Ultrasonic Generator	Olympus Medical Systems Corp.	LFL	Unclassified	2017-10-04
K172671	HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal	ConMed Corporation	GEI	Class II	2017-10-04
K172607	Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	Philips Health Care	IYN	Class II	2017-10-04
K172520	CRE RX Biliary Balloon Dilatation Catheter	Boston Scientific Corporation	FGE	Class II	2017-10-04
K172289	pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent	Q Urological Corporation	FAD	Class II	2017-10-04
K172174	Philips IntelliSite Pathology Solution	Philips Medical Systems Nederland B.V.	PSY	Class II	2017-10-04
K172092	Reprocessed Shavers/Burs	ReNovo, Inc.	HRX	Class II	2017-10-04
K171991	EMPOWR Porous Knee System	Encore Medical, LP	MBH	Class II	2017-10-04
K171182	ri-former Predictive Thermometer	Rudolf Riester GmbH	FLL	Class II	2017-10-04
K172884	Arisure Closed Vial Adapter	Yukon Medical, LLC	LHI	Class II	2017-10-03
K172684	Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem	Smith & Nephew, Inc.	LPH	Class II	2017-10-03
K172621	HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)	Hardy Diagnostics	JTN	Class II	2017-10-03
K172285	Ablatherm Fusion	Edap Technomed Inc.	PLP	Class II	2017-10-03
K172022	CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)	Cerenovus, Inc.	JXG	Class II	2017-10-03
K172016	Force Fiber Fusion Suture	Teleflex Medical Incorporated	GAT	Class II	2017-10-03
K172596	Large Screws Range	Newclip Technics	HWC	Class II	2017-10-02
K172210	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)	Stryker Trauma GmbH	KWS	Class II	2017-10-02
K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10	Shenzhen Dongdixin Technology Co., Ltd.	IPF	Class II	2017-10-02
K171768	Trident® II Acetabular System	Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics	LPH	Class II	2017-10-02
K171250	BRIDALVEIL Occipital Cervical Thoracic System	Astura Medical	NKG	Class II	2017-10-02
K170873	Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl	Swissmeditec GmbH	EBF	Class II	2017-10-02
K170506	ECG Check - Universal, ECG Check - Universal Plus	Cardiac Designs, LLC	DXH	Class II	2017-10-02
K170375	Nobilplast Denture Resin	Cmp Industries, LLC	EBI	Class II	2017-10-02
K170054	iSurg	Jaco, LLC dba Macan Manufacturing and Bna Burz North America	GEI	Class II	2017-10-02
K163183	Yooeehouse Breast Pump	Nantong Poly Technology Co., Ltd.	HGX	Class II	2017-10-02
K172631	Arisure Dry Spike	Yukon Medical, LLC	LHI	Class II	2017-09-29
K172420	Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim	Wear Safe (Malaysia) Sdn Bhd	KGO	Class I	2017-09-29
K172397	Sherlock 3CG Tip Positioning System Stylet	C.R. Bard Inc	LJS	Class II	2017-09-29
K172380	U2 Diagnostic Ultrasound System	Edan Instruments, Inc.	IYN	Class II	2017-09-29
K172342	Voluson E6, Voluson E8, Voluson E10	GE Healthcare	IYN	Class II	2017-09-29