# K102900: Heiter 3000 Hyperthermic Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Hei, Inc.
- Decided: Mar 21, 2012 after 538 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- K092366: TTS100 Portable Hyperthermic Perfusion Device, Thermal Therapeutic Systems, Inc. (2010) Summary page 1.
- K070654: Hyperthermia Pump, Belmont Instrument Corp. (2007) Summary page 1.

## Recalls of this device
- Jun 4, 2021 · Class I · Z-2005-2021: The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.

## Indications for use
The REITER 3000 Hyperthermnic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as saline or Lactated Ringer's.

Source page: https://510kreport.com/device/K102900
Methodology: https://510kreport.com/methodology