# K251733: Fluido® AirGuard System

- Pathway: 510(k) (Traditional)
- Applicant: The Surgical Company International BV (As Tsc Life)
- Decided: Sep 4, 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: 4 generations back to K852645 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141654: The Belmont Rapid Infuser, Belmont Instrument Corporation (2014) Summary page 6.

## Indications for use
Infusion of crystalloid, colloid or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. Infusion of warmed fluid to patients with the ability to prevent hypothermia.

Source page: https://510kreport.com/device/K251733
Methodology: https://510kreport.com/methodology