FDA.reportPublic FDA data

510(k) K252398

Device
SURFLO Hybria Closed System Safety IV Catheter
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
510(k) number
K252398
Product code
FOZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-17
Date received
2025-07-31
Regulation
880.5200
Classification name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Tien Trinh
Address
M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou CN 310018 310018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260432Ruby Intravascular CatheterVenocare, Inc.2026-09-02
K260165Unimpregnated Central Venous CatheterSpectrum Vascular2026-08-10
K261041ClearSafe Closed SystemMedSource Labs, LLC2026-07-10
K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC2026-07-09
K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.2026-05-15
K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2026-04-02
K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited2026-04-01
K252677Polyshield Safety IV CathetersPoly Medicure Limited2025-11-05
K251422BD Saf-T-Intima™ Subcutaneous Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-10-08
K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc.2025-07-25
K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-07-11
K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.2025-06-27
K250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc.2025-06-03
K243105Ruby Intravascular CatheterVenocare, Inc.2025-05-16
K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc.2025-05-02