# K993330: Thermochem-HT System

- Pathway: 510(k) (Traditional)
- Applicant: Hemocleanse, Inc.
- Decided: Dec 30, 1999 after 87 days
- Product code: MLW (Warmer, Peritoneal Dialysate)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070654: Hyperthermia Pump (2007), 5 descendants of its own
- 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

## Indications for use
The intended use of the ThermoChem-HT System is to raise the core temperature of the peritoneum to the desired target temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringers’s Solution, U.S.P., or another physiologically compatible sterile solution.

Source page: https://510kreport.com/device/K993330
Methodology: https://510kreport.com/methodology