SURFLO Hybria Closed System Safety IV Catheter— 510(k) K252398

Name: FDA 510(k) clearance K252398
Creator: U.S. Food and Drug Administration
Published: 2025-12-17

Substantially Equivalent

Terumo Medical Products (Hangzhou) Co., Ltd.

FDA 510(k) clearance K252398 for SURFLO Hybria Closed System Safety IV Catheter, Substantially Equivalent on 2025-12-17. Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2025-07-31
Decision date: 2025-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOZ

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K260432 — Ruby Intravascular Catheter2026-09-02
K260165 — Unimpregnated Central Venous Catheter2026-08-10
K261041 — ClearSafe Closed System2026-07-10
K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

More clearances from Terumo Medical Products (Hangzhou) Co., Ltd.

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K252402 — Midline Catheter2025-12-18
K221411 — Surflo Winged Infusion Set2023-06-23
K220934 — RADIFOCUS Torque Device2022-06-29
K031279 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET2003-05-30

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.