# K040574: Galileo Gold

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical, Inc.
- Decided: Oct 27, 2004 after 237 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: 5 generations back to K902859 (1991). 23 ancestors in all.
53 later devices descend from it; 3 cite it directly.
22 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022679: Raphael, Hamilton Medical AG (2003) Summary page 4.
- K984535: Puritan-Bennett 840 Ventilatory System with Bilevel Option, Puritan Bennett Corp. (1998) Summary page 2.
- K001646: Puritan-Bennett 840 Ventilator System with Neomode Option, Puritan Bennett Corp. (2000) Summary page 2.
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474, Drager Medizintechnik GmbH (2001) Summary page 2.
- K980642: EVITA 4 (8411900), Drager, Inc. (1998) Summary page 2.
- K992608: Atc Option for Evita 2 Dura and Evita 4, Drager, Inc. (1999) Summary page 2.
- K970839: Servo Ventilator 300A, Siemens Elema AB (1997) Summary page 2.
- K010925: Servoi Ventilator System, Model 64 87 800 E407E, Siemens Elema AB (2001) Summary page 2.
- K022132: Servo Ventilator System, Model 64 87 800 E407E, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.

## Most influential descendants
- K051263: Evitaxl with Option Smartcare (2005), 51 descendants of its own
- K061090: Galileo Gold Asv (2006), 36 descendants of its own
- K070513: Hamilton-G5 (2007), 26 descendants of its own
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 (2008), 23 descendants of its own
- K080181: Modification to Galileo Gold (2008), 21 descendants of its own

## Indications for use
The Galileo Gold 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 or 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/K040574
Methodology: https://510kreport.com/methodology