# K032778: Large Volume Fluid Reservoir

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corp.
- Decided: Sep 22, 2003 after 14 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: 3 generations back to K852645 (1985). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972284: Fluid Management System, Belmont Instrument Corp. (1997) Summary page 4.
- K992672: Belmont Fluid Management System (FMS2000), Belmont Instrument Corp. (1999) Summary page 4.

## Most influential descendants
- K052055: Smisson-Cartledge Thermal Infusion System, Model Tis-1200 (2006), 1 descendant of its own
- K202461: ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (2022), 0 descendants of its own

## Indications for use
Infusion of crystalloid, colloid, or blood product, including packed red cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. Infusion of warmed fluid for irrigation in urology purposes. The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.

Source page: https://510kreport.com/device/K032778
Methodology: https://510kreport.com/methodology