# K080181: Modification to Galileo Gold

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Jun 24, 2008 after 152 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K902859 (1991). 46 ancestors in all.
21 later devices descend from it; 2 cite it directly.
15 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061090: Galileo Gold Asv, Hamilton Medical AG (2006) Summary page 1.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.
- K062710: GE Datex-Ohmeda Engstrom Carestation, Datex-Ohmeda, Inc. (2006) Summary page 1.

## Most influential descendants
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 descendants of its own
- K131774: Hamilton-G5 (2013), 10 descendants of its own

## Indications for use
The GALILEO Gold ventilator is intended to provide positive pressure ventilatory support to adult, pediatric, infant, and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use at the patient bedside and for intrafacility transport, provided compressed gas is supplied. The device is not intended for transportation outside the hospital or for use in the home environment.

Source page: https://510kreport.com/device/K080181
Methodology: https://510kreport.com/methodology