# K052863: Raphael Color

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Jan 6, 2006 after 87 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902859 (1991). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982910: Hamilton Medical Galileoventilator, Hamilton Medical, Inc. (1999) Summary page 1.
- K001686: Galileo Ventilator, Hamilton Medical, Inc. (2000) Summary page 1.
- K040574: Galileo Gold, Hamilton Medical, Inc. (2004) Summary page 1.

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

## Recalls of this device
- May 24, 2006 · Not classified · Z-1250-06: ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
- May 24, 2006 · Not classified · Z-1249-06: ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
- May 24, 2006 · Not classified · Z-1251-06: ALARM FAILURE-Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.

## Indications for use
The RAPHAEL Color ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL Color ventilator is intended for use by properly trained personnel under direct supervision of a licensed physician. The RAPHAEL Color 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/K052863
Methodology: https://510kreport.com/methodology