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 630 of 3529

510(k) clearances, page 630 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161825	Pk Aim	Gyrus ACMI, Inc.	GEI	Class II	2016-09-26
K161506	Penumbra Aspiration System	Penumbra Inc.	QEW	Class II	2016-09-26
K161185	LUCERNA Dental Laser	Viax Dental Lab	GEX	Class II	2016-09-26
K160945	Endophys Blood Pressure Monitor	Endophys Holdings, LLC	DSK	Class II	2016-09-26
K160903	STERRAD 100NX Sterilizer with ALLClearTM Technology	Advanced Sterilization Products	MLR	Class II	2016-09-26
K160167	DePuy Synthes TFNA Augmentation System	Synthes (USA) Products LLC	HSB	Class II	2016-09-26
DEN150033	Sensor Monitored Alimentary Restriction Therapy (SMART) Device	Scientific Intake	ONY	Class II	2016-09-26
K162143	FixxSure® X-Link	Innovasis, Inc	MNH	Class II	2016-09-23
K161945	EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)	Encore Medical, LP	JWH	Class II	2016-09-23
K161832	O2vent T	Oventus Manufacturing Pty, Ltd.	LRK	Class II	2016-09-23
K160880	Photonica Professional	Ward Photonics, LLC	OLI	Class II	2016-09-23
K160657	BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube	Becton Dickinson & Co	JKA	Class II	2016-09-23
K160640	PASS XS Spinal System	Medicrea International	NKB	Class II	2016-09-23
K151285	VSP Cranial System	3D Systems, Inc.	PPT	Class II	2016-09-23
K162384	TrailBlazer Angled Support Catheter	Medtronic Vascular, Inc.(Formerly Ev3 Inc.)	DQY	Class II	2016-09-22
K162377	PowerGlide Pro Midline Catheter	C.R. Bard Inc	FOZ	Class II	2016-09-22
K162224	ArtPix Mobile EZ2GO	CMT Medical Technologies, Ltd.	KPR	Class II	2016-09-22
K162188	Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)	VR Medical Technology Co., Ltd.	PNR	Class II	2016-09-22
K161994	Aerin Medical Stylus	Aerin Medical, Inc.	GEI	Class II	2016-09-22
K161992	Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems	Integra LifeSciences Corporation	JXG	Class II	2016-09-22
K161451	BIB Stent Placement Catheter	Numed Inc	NVM	Class II	2016-09-22
K161368	DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)	AGFA Healthcare Corp.	MQB	Class II	2016-09-22
K161068	Ahead 300	Brainscope	PIW	Class II	2016-09-22
K160860	MiniMed Quick-serter	Medtronic, Inc.	KZH	Class II	2016-09-22
K160015	Pure Vu	MOTUS GI Medical Technologies Ltd.	FDF	Class II	2016-09-22
K153761	Emergency Transtracheal Airway Catheter	Cook Incorporated	BWC	Class II	2016-09-22
K153565	Donasorb Silver Wound Dressing	Virchow Biotech Pvt. Ltd.	FRO	Unclassified	2016-09-22
K162411	da Vinci Xi 12 – 8 mm Reducer	Intuitive Surgical, Inc.	NAY	Class II	2016-09-21
K162359	Surefire Guiding Catheter	Surefire Medical, Inc.	DQY	Class II	2016-09-21
K162345	UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge	Neotract Inc	PEW	Class II	2016-09-21
K162339	Scenium	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2016-09-21
K162338	Full Automatic (NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2016-09-21
K162264	Cascadia Interbody System	K2M, Inc	MAX	Class II	2016-09-21
K162112	Caas Mrv	PIE Medical Imaging B.V.	LLZ	Class II	2016-09-21
K162016	Affinity NT Oxygenator with Cortiva BioActive Surface	Medtronic, Inc.	DTZ	Class II	2016-09-21
K161879	Solitaire Platinum Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	NRY	Class II	2016-09-21
K161843	Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0	Toshibamedical Systems Corporation	IYN	Class II	2016-09-21
K161746	ARIX Hand System	Jeil Medical Corporation	HRS	Class II	2016-09-21
K161591	QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments	Globus Medical, Inc.	NKG	Class II	2016-09-21
K161439	E-Cube 11	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2016-09-21
K161151	Spinal fixation system	Canwell Medical Co., Ltd.	MNH	Class II	2016-09-21
K160816	Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)	Nexmed Technology Co., Ltd.	FLL	Class II	2016-09-21
K160413	Sterling 5W Diode Laser	Cao Group, Inc.	GEX	Class II	2016-09-21
K160207	ATLANTIS ISUS Implant Suprastructures	Dentsply International, Inc.	NHA	Class II	2016-09-21
K151090	CPL Insulin Pen Needle	Cpl Co., Ltd.	FMI	Class II	2016-09-21
K162306	SomnoDent ALPHA	Somnomed Inc.	LRK	Class II	2016-09-20
K161887	Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip	Volcano Corporation	DQX	Class II	2016-09-20
K161792	PINPOINT Endoscopic Fluorescence Imaging System	Novadaq Technologies ULC	GCJ	Class II	2016-09-20
K161721	Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set	Diazyme Laboratories, Inc.	CDD	Class II	2016-09-20
K161717	Personal Kinetigraph (PKG) System	GKC Manufacturing Pty Ltd	GYD	Class II	2016-09-20