# K992672: Belmont Fluid Management System (FMS2000)

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corp.
- Decided: Aug 24, 1999 after 14 days
- Product code: FRN (Pump, Infusion)
- 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: 2 generations back to K852645 (1985). 2 ancestors in all.
3 later devices descend from it; 2 cite 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 1.

## Most influential descendants
- K032778: Large Volume Fluid Reservoir (2003), 2 descendants of its own
- 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
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/K992672
Methodology: https://510kreport.com/methodology