# K211618: Fluido Compact Blood and Fluid Warming System

- Pathway: 510(k) (Traditional)
- Applicant: The Surgical Company International B.V.
- Decided: Jun 5, 2023 after 740 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: 5 generations back to K770232 (1977). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112902: Enflow IV Fluid Warmer, Vital Signs, Inc. (2012) Summary page 4.

## Most influential descendants
- K252636: Fluido Compact System (2025), 0 descendants of its own

## Indications for use
The Fluido Compact Blood and Fluid Warming System can be used in adult patients that need fluid warming prior to administration of blood, blood products and IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.

Source page: https://510kreport.com/device/K211618
Methodology: https://510kreport.com/methodology