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510(k) K252636

Fluido Compact System by The Surgical Company International B.V. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2025
Date Received
August 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by The Surgical Company International B.V.

  • K211618 — Fluido Compact Blood and Fluid Warming System (June 5, 2023)
  • K101705 — MISTRAL-AIR WARMING SYSTEM (July 2, 2010)

Other clearances for product code LGZ

  • K251733 — Fluido® AirGuard System (September 4, 2025)
  • K232107 — °M Warmer System (May 31, 2024)
  • K211618 — Fluido Compact Blood and Fluid Warming System (June 5, 2023)
  • K211800 — Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior (December 8, 2022)
  • K202461 — ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion Sys (August 12, 2022)
  • K213191 — S-Line (May 24, 2022)
  • K192325 — Quantum Blood and Fluid Warming System (October 18, 2019)
  • K180842 — MAC Medical D-Series Blanket and Solution Warming Cabinets (March 5, 2019)
  • K181775 — Quantum Blood and IV Fluid Infusion Warmer (January 28, 2019)
  • K180154 — QiF Blood and Fluid Warmer (April 27, 2018)