# K061090: Galileo Gold Asv

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Jul 17, 2006 after 90 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: 7 generations back to K902859 (1991). 27 ancestors in all.
36 later devices descend from it; 4 cite it directly.
20 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040574: Galileo Gold, Hamilton Medical, Inc. (2004) Summary page 1.
- K051263: Evitaxl with Option Smartcare, Drager Medical AG & Co. Kgaa (2005) Summary page 1.

## Most influential descendants
- K070513: Hamilton-G5 (2007), 26 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own

## Indications for use
The GALILEO GoldAsv ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, and infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside for intra-facility 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/K061090
Methodology: https://510kreport.com/methodology