# K152208: The Belmont Hyperthermia Pump

- Pathway: 510(k) (Special)
- Applicant: Belmont Instrument Corporation
- Decided: Sep 2, 2015 after 26 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993330 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070654: Hyperthermia Pump, Belmont Instrument Corp. (2007) Summary page 4.
- K090089: Belmont Hyperthermia Pump, Belmont Instrument Corp. (2009) Summary page 4.

## Recalls of this device
- Mar 31, 2025 · Class II · Z-1676-2025: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
- Mar 31, 2025 · Class II · Z-1675-2025: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
- Mar 31, 2025 · Class II · Z-1674-2025: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

## Indications for use
The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

Source page: https://510kreport.com/device/K152208
Methodology: https://510kreport.com/methodology