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510(k) K251733

Fluido® AirGuard System by The Surgical Company International BV (As Tsc Life) — Product Code LGZ

K251733 is an FDA 510(k) premarket notification submitted by The Surgical Company International BV (As Tsc Life) for the device "Fluido® AirGuard System". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
June 6, 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 for product code LGZ

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  • 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)

FDA data resources