Cleared Traditional

Fluido Compact System

K252636 · The Surgical Company International B.V. · General Hospital
Nov 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K252636 is an FDA 510(k) clearance for the Fluido Compact System, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by The Surgical Company International B.V. (Amsterdam, NL). The FDA issued a Cleared decision on November 18, 2025, 90 days after receiving the submission on August 20, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K252636 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2025
Decision Date November 18, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LGZ — Warmer, Thermal, Infusion Fluid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — LGZ Warmer, Thermal, Infusion Fluid

All 73
Fluido? AirGuard System
K251733 · The Surgical Company International BV (As Tsc Life) · Sep 2025
?M Warmer System
K232107 · Mequ A/S · May 2024
Fluido Compact Blood and Fluid Warming System
K211618 · The Surgical Company International B.V. · Jun 2023
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
K211800 · Quality IN Flow , Ltd. · Dec 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
K202461 · Smisson-Cartledge Biomedical, LLC · Aug 2022
S-Line
K213191 · Barkey GmbH & Co. KG · May 2022