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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 819 of 3530

510(k) clearances, page 819 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132359	MRI Patient Monitoring System	Invivo Corporation	MWI	Class II	2013-08-30
K132281	ReVive PV (Peripheral Vasculature) Thrombectomy Device	Cerenovus, Inc.	QEW	Class II	2013-08-30
K132207	Utf Stem-Reduced, Additional Sizes	United Orthopedic Corp.	LPH	Class II	2013-08-30
K132146	Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (Etafilcon a)	St. Shine Optical Co., Ltd.	LPL	Class II	2013-08-30
K131818	Vital Signs Monitor	Edan Instruments, Inc.	DQA	Class II	2013-08-30
K131784	Range Spinal System	K2M, Inc	OSH	Class II	2013-08-30
K131576	Optima Ct660	GE Healthcare	JAK	Class II	2013-08-30
K131558	Pg-800B Series, Including Pg-800Bd, Pg-800B-1, Pg-800Bd-1, Pg-800B3, Pg-800B4, Pg-800B4d, Pg-800B5, Pg-800B5-1, Pg-800B6	Shenzhen Pango Electronic Co., Ltd.	DXN	Class II	2013-08-30
K131455	Restore Modular Sterilization Tray System	Restore Medical Solutions, Inc.	KCT	Class II	2013-08-30
K131430	Clearfil Dc Activator; Clearfil Dc Activator Trial	Kuraray Noritake Dental, Inc.	KLE	Class II	2013-08-30
K131378	Sus (Stenfilcon a) Contact Lens	CooperVision, Inc.	LPL	Class II	2013-08-30
K131363	Onetouch Verio Blood Glucose Monitoring System	Cilag GmbH International	NBW	Class II	2013-08-30
K131241	Swip	Philips Medical Systems Nederland B.V.	LNH	Class II	2013-08-30
K131184	Integra Licox Pto2 Monitor	Integra LifeSciences Corporation	GWM	Class II	2013-08-30
K130931	Easy Day (Methafilcon a) 1-Day Soft (Hydrophilic) Contact Lens	Jiangsu Horien Contact Lens Co., Ltd.	LPL	Class II	2013-08-30
K130792	Lifestent Biliary Stent System, Lifestent Xl Biliary Stent System	C.R. Bard Inc	FGE	Class II	2013-08-30
K130610	Sirius Femoral Stem	Zimmer GmbH	JDI	Class II	2013-08-30
K130165	Pictzar Digital Planimetry Software Application 7.0	Advanced Planimetric Services, LLC	FXN	Class I	2013-08-30
K124044	Aloe Cadabra Lubricant, Aloe Cadabra Flavored/scented Lubricants	Seven Oaks Ranch, Inc.	NUC	Class II	2013-08-30
K123792	Horizon Xvu (Ffr)	Mennen Medical, Inc.	DQX	Class II	2013-08-30
K132587	Md242c2 24 Diagnostic Imaging Lcd Monitor	Ned Display Solutions, Ltd.	LLZ	Class II	2013-08-29
K132413	Mz1000	Care Fusion	FPA	Class II	2013-08-29
K132409	Concierge Guiding Catheter	Merit Medical Systems, Inc.	DQY	Class II	2013-08-29
K132012	Trinica(r) Anterior Cervical Plate System, Trinica(r) Select Anterior Cervical Plate System	Zimmer Spine, Inc.	KWQ	Class II	2013-08-29
K131780	Evis Exera III Video System	Olympus Medical Systems Corp.	FDF	Class II	2013-08-29
K131728	Quidel Molecular Influenza a + B Assay	Ortho-Clinical Diagnostics, Inc.	OZE	Class II	2013-08-29
K131635	Rotation Medical Bone Staple (Rmb Staple)	Rotation Medical, Inc.	MBI	Class II	2013-08-29
K131616	Ez3d-I, E3	Ewoosoft Co., Ltd	LLZ	Class II	2013-08-29
K131614	Reprocessed Closurefast Radiofrequency Catheter 60Cm, Reprocessed Closurefast Radiofrequency Catheter 100Cm	Medtronic, Inc.	NUJ	Class II	2013-08-29
K131611	Fresenius Dry Acid Dissolution Units	Fresenius Medical Care Renal Therapies Group, LLC	KPO	Class II	2013-08-29
K131594	Ezdenti-I; E2; Prora View	Ewoosoft Co., Ltd	LLZ	Class II	2013-08-29
K131408	Cr 12-X Digitizer	AGFA Healthcare Corp.	MQB	Class II	2013-08-29
K131294	Omnipod Insulin Management System	Insulet Corporation	LZG	Class II	2013-08-29
K131200	Aspiron Acp System	CG MedTech Co., Ltd.	KWQ	Class II	2013-08-29
K130868	Nuvasive Decade Lateral Plate System	NuVasive Inc	KWQ	Class II	2013-08-29
K130727	Ensite Velocity System	Abbott Medical	DQK	Class II	2013-08-29
K130374	Omni-Vue 2 System	Genesis Digital Imaging, Inc.	LLZ	Class II	2013-08-29
K130266	Endowrist One Vessel Sealer	Intuitive Surgical, Inc.	NAY	Class II	2013-08-29
K130242	Maven Pro	Nsequence	LLZ	Class II	2013-08-29
K123947	Architect Ivancomycin	Biokit, S.A.	LEH	Class II	2013-08-29
K123540	Syngo CT Pulmo 3D	Siemens Medical Solutions USA, Inc.	JAK	Class II	2013-08-29
K122885	Medisize Gold Heater and Booster T-Piece	Medisize BV	BTT	Class II	2013-08-29
K132234	Liaison(r) Toxo Igg II, Liaison(r) Control Toxo Igg II	Diasorin Inc.	LGD	Class II	2013-08-28
K131641	Monoject 60Ml Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)	Nipro Medical Corporation	FMF	Class II	2013-08-28
K131582	Sensus Helthcare Image-Duided Superficial Radiotherapy System	Sensus Healthcare	JAD	Class II	2013-08-28
K131507	Xario 200 Diagnostic Ultrasound System	Toshibamedical Systems Corporation	IYN	Class II	2013-08-28
K131471	Self-Compressive Screw	Neosteo	HWC	Class II	2013-08-28
K131414	Carescape Monitor B850	GE Healthcare Finland Oy	MHX	Class II	2013-08-28
K131277	Seviin Fracture Shoulder	Ingen Orthopedics, LLC	KWS	Class II	2013-08-28
K131223	Carescape Monitor B650	GE Healthcare Finland Oy	MHX	Class II	2013-08-28