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 622 of 3529

510(k) clearances, page 622 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162892	Achieve Advance Mapping Catheter	Medtronic, Inc.	DRF	Class II	2016-11-15
K162278	Digital Diagnostic Mobile X-ray System	Samsung Electronics Co., Ltd.	IZL	Class II	2016-11-15
K162265	CushionCast Moldable Cushions	Izi Medical Products LLC	IYE	Class II	2016-11-15
K161856	StatStrip Xpress Glucose Hospital Meter System	Nova Biomedical Corporation	PZI	Class II	2016-11-15
K161831	IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set	Immunodiagnostic Systems Ltd.	MRG	Class II	2016-11-15
K161753	Hoffman LRF System	Stryker Corp.	KTT	Class II	2016-11-15
K161742	Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid	TORNIER Inc.	PHX	Class II	2016-11-15
K161665	VLP Wrist Fracture System	Smith & Nephew, Inc.	HRS	Class II	2016-11-15
K161515	eUnity	Client Outlook, Inc.	LLZ	Class II	2016-11-15
K161494	Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)	Siemens Healthcare Diagnostics Inc.	CGX	Class II	2016-11-15
K160881	Tablo Console	Outset Medical, Inc.	KDI	Class II	2016-11-15
K160791	AmorChem Titanium Porous Fixation Device	Amorchem Holdings, Inc.	HWC	Class II	2016-11-15
K160512	HardyCHROM ESBL	Hardy Diagnostics	JSO	Class II	2016-11-15
K160166	X-MIND trium	De Gotzen S.r.l.	OAS	Class II	2016-11-15
K160049	Charisma	Heraeus Kulzer, LLC (Mitsui Chemicals Group)	EBF	Class II	2016-11-15
K153714	SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co	Synergeyes, Inc.	HQD	Class II	2016-11-15
K153409	Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)	Protect U Guard, LLC	FXX	Class II	2016-11-15
K162941	Ligasure Blunt Tip, Sealer/Divider, Nano-coated	Medtronic, Inc.	GEI	Class II	2016-11-14
K162457	Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit	Rocket Medical	PNG	Class II	2016-11-14
K162252	FasTouch Fixation System	Via Surgical, Ltd.	GDW	Class II	2016-11-14
K161862	ThermoPro	Zimmer Medizinsysteme GmbH	IMJ	Class II	2016-11-14
K160718	Vital Sync Informatics Manager & Virtual Patient Monitoring Platform	Medtronic, Inc.	MWI	Class II	2016-11-14
K153656	PathLoc-SI Joint Fusion System	L&K Biomed Co.,Ltd.	OUR	Class II	2016-11-14
K162656	ESU-1 Electrosurgical Generator	Tva Medical, Inc.	GEI	Class II	2016-11-10
K162576	FORTEZZA Spinal Stabilization System	Osso Surgical	NKB	Class II	2016-11-10
K162539	Solitaire 2 Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	POL	Class II	2016-11-10
K162310	XBraid TT Suture Tape	Stryker Corp.	GAT	Class II	2016-11-10
K162085	i-CAT FLX V series / KaVo 3D eXam+ V series	Dental Imaging Technologies Corporation	OAS	Class II	2016-11-10
K161738	FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems	Taidoc Technology Corporation	NBW	Class II	2016-11-10
K161634	IPS CaseDesigner	Nobel Biocare AB	LLZ	Class II	2016-11-10
K161628	JAS Pulse(TM) Ultrasonic Therapy	Bonutti Research, Inc.	IMI	Class II	2016-11-10
K161623	Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL	B.Braun Medical, Inc.	FRO	Unclassified	2016-11-10
K161417	DePuy Synthes MAXFRAME Multi-Axial Correction System	Synthes (USA) Products LLC	KTT	Class II	2016-11-10
K160447	Calprest NG	Eurospital S.p.A.	NXO	Class II	2016-11-10
K160190	Sunmed Control Syringes	Sunny Medical Device (Shenzhen) Co., Ltd.	DXT	Class II	2016-11-10
K160127	iCodeConnect	3B Medical Inc	BZD	Class II	2016-11-10
K160079	rainbow Shine	GENOSS Co., Ltd.	EIH	Class II	2016-11-10
K162862	Raycast High Precision Lung Board Solution	Orfit Industries NV	IYE	Class II	2016-11-09
K162781	Magma Spark	Formatk Systems Ltd.	GEX	Class II	2016-11-09
K162262	Tritanium® PL Cage	Stryker Corp.	MAX	Class II	2016-11-09
K161768	LUCAS 3 Chest Compression System	Jolife AB	DRM	Class II	2016-11-09
K161649	Virtu C Spinal Implant System	Met 1 Technologies, LLC	ODP	Class II	2016-11-09
K161610	EXPRT Revision Hip System	Encore Medical, LP	KWZ	Class II	2016-11-09
K161433	Insulia Diabetes Management Companion	Voluntis	NDC	Class II	2016-11-09
K160481	Vivo 60	Breas Medical AB	NOU	Class II	2016-11-09
K152660	Hypnospad	Somnics, Inc.	LRK	Class II	2016-11-09
K161493	YO Home Sperm Test	Medical Electronic Systems Ltd.	POV	Class II	2016-11-08
K161438	Genesys Spine Apache® Anterior Lumbar Interbody Fusion System	Genesys Spine	MAX	Class II	2016-11-08
K161027	Cadwell AmpliScan	Cadwell Industries Inc	OMA	Class II	2016-11-08
K161011	SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive	Adhezion Biomedical, LLC	MPN	Class II	2016-11-08