Fluido Compact System— 510(k) K252636

Name: FDA 510(k) clearance K252636
Creator: U.S. Food and Drug Administration
Published: 2025-11-18

Substantially Equivalent

The Surgical Company International B.V.

FDA 510(k) clearance K252636 for Fluido Compact System, Substantially Equivalent on 2025-11-18. Applicant: The Surgical Company International B.V.. Device class: 2.

Clearance details

Applicant: The Surgical Company International B.V.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2025-08-20
Decision date: 2025-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

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K232107 — °M Warmer System2024-05-31
K211618 — Fluido Compact Blood and Fluid Warming System2023-06-05
K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer2022-12-08

More clearances from The Surgical Company International B.V.

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K101705 — MISTRAL-AIR WARMING SYSTEM2010-07-02

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.