# K141654: The Belmont Rapid Infuser

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corporation
- Decided: Jul 18, 2014 after 28 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: 3 generations back to K852645 (1985). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972284: Fluid Management System, Belmont Instrument Corp. (1997) Summary page 2.
- K032674: Belmont Fluid Management System, Model FMS2000, Belmont Instrument Corp. (2003) Summary page 1.
- K091855: The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model  FMS2000, Belmont Instrument Corp. (2009) Summary page 1.

## Most influential descendants
- 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

## 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/K141654
Methodology: https://510kreport.com/methodology