# K982910: Hamilton Medical Galileoventilator

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical, Inc.
- Decided: Sep 14, 1999 after 392 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K052863: Raphael Color (2006), 1 descendant of its own
- K071194: Raphael Color Asv Ventilator (2007), 0 descendants of its own

## Indications for use
The Galileo Ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients. The device is intended for use in the hospital and institutional environment by health care professionals. The device is not intended for transport outside of the hospital or institutional environment.

Source page: https://510kreport.com/device/K982910
Methodology: https://510kreport.com/methodology