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510(k) K252402

Midline Catheter by Terumo Medical Products (Hangzhou) Co., Ltd. — Product Code PND

K252402 is an FDA 510(k) premarket notification submitted by Terumo Medical Products (Hangzhou) Co., Ltd. for the device "Midline Catheter". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code PND (Midline Catheter), a Class II device regulated under 21 CFR 880.5200. Terumo Medical Products (Hangzhou) Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
July 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Midline Catheter
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.

Other clearances by Terumo Medical Products (Hangzhou) Co., Ltd.

  • K252398 — SURFLO Hybria Closed System Safety IV Catheter (December 17, 2025)
  • K221411 — Surflo Winged Infusion Set (June 23, 2023)
  • K220934 — RADIFOCUS Torque Device (June 29, 2022)

Other clearances for product code PND

  • K213855 — Arrow Pressure Injectable Midline Catheter (September 2, 2022)
  • K213203 — Provena(TM) Midline Catheter (May 13, 2022)
  • K210047 — Stiletto Extended Dwell Catheter (August 27, 2021)
  • K192802 — primeMidline Catheters (October 28, 2019)
  • K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 (November 2, 2018)
  • K173114 — primeMidline Catheters (March 7, 2018)
  • K171483 — ArchFlo CT Midline (December 15, 2017)
  • K170770 — CT Midline (July 25, 2017)
  • K170158 — PowerGlide ST Midline Catheter (June 1, 2017)
  • K162900 — PowerMidline Catheter (December 14, 2016)

FDA data resources