# K071194: Raphael Color Asv Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Oct 18, 2007 after 171 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). 30 ancestors in all.
No later device cites it as a predicate yet.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052863: Raphael Color, Hamilton Medical AG (2006) Summary page 1.
- K061090: Galileo Gold Asv, Hamilton Medical AG (2006) Summary page 1.

## Indications for use
The RAPHAEL ColorAsv ventilator is a continuous ventilator designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. The RAPHAEL ColorAs v ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color Asv is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.

Source page: https://510kreport.com/device/K071194
Methodology: https://510kreport.com/methodology