# K091855: The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model  FMS2000

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corp.
- Decided: Jul 1, 2009 after 8 days
- Product code: FRN (Pump, Infusion)
- 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K141654: The Belmont Rapid Infuser (2014), 2 descendants 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

## 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.

Source page: https://510kreport.com/device/K091855
Methodology: https://510kreport.com/methodology