# K092366: TTS100 Portable Hyperthermic Perfusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Thermal Therapeutic Systems, Inc.
- Decided: Mar 4, 2010 after 211 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: 2 generations back to K993330 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 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 2.
- K070654: Hyperthermia Pump, Belmont Instrument Corp. (2007) Summary page 2.

## Most influential descendants
- K102900: Heiter 3000 Hyperthermic Perfusion System (2012), 0 descendants of its own

## Indications for use
The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

Source page: https://510kreport.com/device/K092366
Methodology: https://510kreport.com/methodology