# K972284: Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Belmont Instrument Corp.
- Decided: Nov 13, 1997 after 147 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
Longest line of descent: 1 generation back to K852645 (1985). 1 ancestor in all.
9 later devices descend from it; 6 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852645: Fluid Management System, Haemonetics Corp. (1985) Summary page 1.

## Most influential descendants
- K032674: Belmont Fluid Management System, Model FMS2000 (2003), 5 descendants of its own
- K992672: Belmont Fluid Management System (FMS2000) (1999), 3 descendants of its own
- K141654: The Belmont Rapid Infuser (2014), 2 descendants of its own
- K032778: Large Volume Fluid Reservoir (2003), 2 descendants of its own
- K983975: Belmont Fluid Management System (FMS2000) (1998), 2 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/K972284
Methodology: https://510kreport.com/methodology