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 555 of 3529

510(k) clearances, page 555 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172819	LightWalker Laser System Family	Fotona d.o.o.	GEX	Class II	2017-12-01
K172666	CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor	Sutureease, Inc.	OCW	Class II	2017-12-01
K172503	MR Conditional Cup Electrode, MR Conditional Webb Electrode	Rhythmlink International, LLC	GXY	Class II	2017-12-01
K172255	MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2017-12-01
K172008	ARIX Humerus System	Jeil Medical Corporation	HRS	Class II	2017-12-01
K171935	Alevicyn SG Antimicrobial Gel	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2017-12-01
K171773	Straumann n!ce Glass Ceramic A14 Blocks	Straumann USA, LLC	NHA	Class II	2017-12-01
K171352	EZFluence	Radformation, Inc.	IYE	Class II	2017-12-01
K171185	IR Type Implant System	Biotem Co., Ltd.	DZE	Class II	2017-12-01
K170553	Altus Spine Interbody Fusion System	Altus Partners	MAX	Class II	2017-12-01
K170392	S.I.N. Implant System	S.I.N. Implant System Ltda	DZE	Class II	2017-12-01
K173522	Solanas® Posterior Stabilization System	Alphatec Spine, Inc.	NKB	Class II	2017-11-30
K173399	Endophys Pressure Sensing Sheath Kit- 8F	Endophys Holdings, LLC	DYB	Class II	2017-11-30
K173385	Graft Delivery, DePuy Synthes	Micromedics, Inc. (D/B/A Nordson Medical)	FMF	Class II	2017-11-30
K173233	ReliefBand 1.5	ReliefBand Technologies	GZJ	Class II	2017-11-30
K173099	Fortis and Hana Anterior Cervical Plate System	Huvexel Co., Ltd.	KWQ	Class II	2017-11-30
K172936	Destiknee™ Total Knee System	Meril Healthcare Pvt. Ltd.	JWH	Class II	2017-11-30
K172925	Contact Lens Case, Model: A-1, B-1	P L Overseas Limited	LRX	Class II	2017-11-30
K172769	CryOmega Flexx	Cryoconcepts LP	GEH	Class II	2017-11-30
K172767	Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid	Zimmer GmbH	PHX	Class II	2017-11-30
K172637	HeRO Graft	Merit Medical Systems, Inc.	DSY	Class II	2017-11-30
K172538	Disposable Linear Stapler, Disposable Linear Cutter	Changzhou Kangdi Medical Stapler Co., Ltd.	GDW	Class II	2017-11-30
K172469	TiLock Modular Spinal System	Genesys Spine	NKB	Class II	2017-11-30
K172225	Atlantis Abutment for MIS Implant	Dentsply Sirona Inc	NHA	Class II	2017-11-30
K171934	Birmingham Hip (BH) Dual Mobility Insert	Smith & Nephew, Inc.	LPH	Class II	2017-11-30
K171578	Infrared thermometer	Shenzhen Aeon Technology Co.,Ltd	FLL	Class II	2017-11-30
K171571	NexSite HD, Hemodialysis Step Tip Catheter (60cm)	Marvao Medical Devices Ltd.	MSD	Class II	2017-11-30
K170868	FIXIT Threaded Anchor System	S.B.M SAS Science for Bio Materials	MAI	Class II	2017-11-30
K162718	Foot Drop System (Model XFT-2001D)	Shenzhen XFT Medical Limited	GZI	Class II	2017-11-30
K172794	Suction Irrigation Set	WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.	GCJ	Class II	2017-11-29
K172771	Epic Pro 940	Biolase, Inc.	GEX	Class II	2017-11-29
K172689	DESCRIBE PFD Patch	Merz North America, Inc.	PKO	Class II	2017-11-29
K172491	ICONN Square 2.5MM Suture Anchor	Iconn Orthopedics, LLC	MBI	Class II	2017-11-29
K172067	One Mum Pumpset	Ardo Medical AG	HGX	Class II	2017-11-29
K172020	Arlington PLIF/TLIF Cage	Signature Orthopaedics Pty Limited	MAX	Class II	2017-11-29
K172019	Brisbane ALIF Device, Gladstone ALIF Device	Signature Orthopaedics Pty Limited	OVD	Class II	2017-11-29
K171803	HIVOX OTC Electrical Stimulator	Hivox Biotek Inc.	NUH	Class II	2017-11-29
K171694	s-Clean TiN Coating Abutments	Dentis Co.,Ltd	NHA	Class II	2017-11-29
K171466	NobelDesign, DTX Studio Design	Nobel Biocare AB	NHA	Class II	2017-11-29
K171350	Collision Check	Radformation, Inc.	IYE	Class II	2017-11-29
K170690	M-Vizion Femoral Revision System	Medacta International SA	LZO	Class II	2017-11-29
K170634	Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350	Advanced Vehicle Concepts, Ltd.	INI	Class II	2017-11-29
K170235	Lucent®	Spinal Elements, Inc	MAX	Class II	2017-11-29
DEN170041	GeneSTAT.MDx Coccidioides Assay	Dxna, LLC	QAA	Class II	2017-11-29
K173377	3.0T 16ch Breast Coil	NeoCoil, LLC	MOS	Class II	2017-11-28
K173290	DuoFLEX Coil Suite	Mr Instruments, Inc.	MOS	Class II	2017-11-28
K173121	Ankle Fusion Plating System	In2Bones SAS	HRS	Class II	2017-11-28
K173111	LAP-iX Suction Irrigation	Sejong Medical Co., Ltd.	HET	Class II	2017-11-28
K173006	Cefaly Dual	Cefaly Technology	PCC	Class II	2017-11-28
K172642	Orange Non Sterile Powder Free Nitrile Examination Gloves	Central Medicare Sdn Bhd	LZC	Class I	2017-11-28