SURFLO Hybria Closed System Safety IV Catheter

Q: What is the product code of K252398?

The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.

FDA 510(k) K252398 · Terumo Medical Products (Hangzhou) Co., Ltd.

Substantially Equivalent

510(k) numberK252398

Submission

Device name: SURFLO Hybria Closed System Safety IV Catheter
Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
Hangzhou, CN
Received: July 31, 2025
Decision date: December 17, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5200
Specialty: General Hospital

Other 510(k)s with product code FOZ

510(k)	Device	Applicant	Decision
K260432	Ruby Intravascular CatheterFOZ · Traditional	Venocare, Inc.	09/02/2026SE
K260165	Unimpregnated Central Venous CatheterFOZ · Traditional	Spectrum Vascular	08/10/2026SE
K261041	ClearSafe Closed SystemFOZ · Traditional	MedSource Labs, LLC	07/10/2026SE
K260539	MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional	MedSource Labs, LLC	07/09/2026SE
K253235	Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional	B.Braun Medical, Inc.	05/15/2026SE
K252137	BD Insyte IV CatheterFOZ · Traditional	Becton Dickinson Infusion Therapy Systems, Inc.	04/02/2026SE
K252513	Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special	Poly Medicure Limited	04/01/2026SE
K252677	Polyshield Safety IV CathetersFOZ · Special	Poly Medicure Limited	11/05/2025SE
K251422	BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional	Becton Dickinson Infusion Therapy Systems, Inc.	10/08/2025SE
K243403	BD Nexiva Closed IV Catheter SystemFOZ · Traditional	Becton Dickinson Infusion Therapy Systems, Inc.	07/25/2025SE

More from Becton Dickinson Infusion Therapy Systems, Inc.

510(k)	Device	Decision
K252402	Midline CatheterPND · Traditional	12/18/2025SE
K221411	Surflo Winged Infusion SetFPA · Traditional	06/23/2023SE
K220934	RADIFOCUS Torque DeviceMOF · Traditional	06/29/2022SE
K031279	Surshield Safety Winged Blood Collection SetFPA · Traditional	05/30/2003SE

Questions and answers

When was SURFLO Hybria Closed System Safety IV Catheter cleared by the FDA?

SURFLO Hybria Closed System Safety IV Catheter (K252398) received a 510(k) decision of Substantially Equivalent on December 17, 2025, 139 days after the submission was received.

What is the product code of K252398?

The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.