# K120026: Performer HT/ Hang&GO HT Basic

- Pathway: 510(k) (Traditional)
- Applicant: Rand S.R.L.
- Decided: May 8, 2012 after 126 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.
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 1.

## Most influential descendants
- K161613: Hang&Go PAC (2016), 0 descendants of its own

## Indications for use
The intended use of the PERFORMER UT is to provide isolated hyperthermic perfusion in the thoracic or peritonecal cavity by means of extra-corporeal circulation of warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician. The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Source page: https://510kreport.com/device/K120026
Methodology: https://510kreport.com/methodology