# K252636: Fluido Compact System

- Pathway: 510(k) (Traditional)
- Applicant: The Surgical Company International B.V.
- Decided: Nov 18, 2025 after 90 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K770232 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211618: Fluido Compact Blood and Fluid Warming System, The Surgical Company International B.V. (2023) Summary page 6.

## Indications for use
The device can be used with the following products: • Plasma • Packed red blood cells • Crystalloid intra venous (IV) fluids • Synthetic Colloid intra venous (IV) fluids The system is indicated to be used in a healthcare environment to help prevent hypothermia. The devices can be used in the full clinical environment. The Fluido Compact System can be used in adult and pediatric patients (weighing 3.5 kg or more) who require fluid warming prior to the administration of blood products or IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, and doctors.

Source page: https://510kreport.com/device/K252636
Methodology: https://510kreport.com/methodology