# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Belmont Medical Technologies
- Decided: Dec 23, 2024 after 103 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K852645 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141654: The Belmont Rapid Infuser, Belmont Instrument Corporation (2014) Summary page 5.

## Recalls of this device
- Mar 31, 2025 · Class II · Z-1678-2025: Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
- Jan 2, 2025 · Class II · Z-1099-2025: Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by 

## Indications for use
The Belmont Rapid Infuser RI-2 is designed to be used in general operation in hospital or alternative care environments to provide warmed blood and fluids to any patients ≥ 10 kg requiring warmed infusion from 2.5 mL/min to 1000 mL/min. - 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. - Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. - Infusion of warmed fluid for irrigation in urology procedures. The 3.0L reservoir is an optional accessory for use in adults only.

Source page: https://510kreport.com/device/K242735
Methodology: https://510kreport.com/methodology