# K032674: Belmont Fluid Management System, Model FMS2000

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corp.
- Decided: Sep 16, 2003 after 18 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852645 (1985). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 8 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.

## Most influential descendants
- K141654: The Belmont Rapid Infuser (2014), 2 descendants of its own
- K052055: Smisson-Cartledge Thermal Infusion System, Model Tis-1200 (2006), 1 descendant of its own
- K251733: Fluido® AirGuard System (2025), 0 descendants of its own
- K242735: Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (2024), 0 descendants of its own
- K202461: ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (2022), 0 descendants of its own

## Recalls of this device
- Sep 25, 2012 · Class II · Z-0058-2013: Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.

## Indications for use
A. 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. B. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. C. Infusion of warmed fluid for irrigation in urology procedures.

Source page: https://510kreport.com/device/K032674
Methodology: https://510kreport.com/methodology