Cleared Traditional

SURFLO Hybria Closed System Safety IV Catheter

K252398 · Terumo Medical Products Hangzhou Co., Ltd. · General Hospital

Dec 2025

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K252398 is an FDA 510(k) clearance for the SURFLO Hybria Closed System Safety IV Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Terumo Medical Products Hangzhou Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 17, 2025, 139 days after receiving the submission on July 31, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K252398 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2025
Decision Date	December 17, 2025
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200