# K070654: Hyperthermia Pump

- Pathway: 510(k) (Traditional)
- Applicant: Belmont Instrument Corp.
- Decided: Jun 8, 2007 after 91 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- 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: 1 generation back to K993330 (1999). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993330: Thermochem-HT System, Hemocleanse, Inc. (1999) Summary page 4.

## Most influential descendants
- K120026: Performer HT/ Hang&GO HT Basic (2012), 1 descendant of its own
- K092366: TTS100 Portable Hyperthermic Perfusion Device (2010), 1 descendant of its own
- K161613: Hang&Go PAC (2016), 0 descendants of its own
- K152208: The Belmont Hyperthermia Pump (2015), 0 descendants of its own
- K102900: Heiter 3000 Hyperthermic Perfusion System (2012), 0 descendants of its own

## 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/K070654
Methodology: https://510kreport.com/methodology