Cleared Traditional

Midline Catheter

K252402 · Terumo Medical Products Hangzhou Co., Ltd. · General Hospital

Dec 2025

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K252402 is an FDA 510(k) clearance for the Midline Catheter, a Midline Catheter (Class II — Special Controls, product code PND), submitted by Terumo Medical Products Hangzhou Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 18, 2025, 140 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	K252402 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2025
Decision Date	December 18, 2025
Days to Decision	140 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PND — Midline Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	The Catheter Is Inserted Into The Peripheral Vascular System For Infusion Of Fluids And Medications For Less Than 28 Days.