# K022679: Raphael

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Oct 22, 2003 after 436 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: 4 generations back to K902859 (1991). 11 ancestors in all.
54 later devices descend from it; 1 cites it directly.
21 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001686: Galileo Ventilator, Hamilton Medical, Inc. (2000). Our reading of the summary gave K001685, FDA’s number for PSN Hemodialyzer, Model PSN 130, 150, 170, 210 (Baxter Healthcare Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Galileo”. Summary page 1.
- K970165: Evita 2 Dura, Drager, Inc. (1997) Summary page 1.
- K010925: Servoi Ventilator System, Model 64 87 800 E407E, Siemens Elema AB (2001) Summary page 1.
- K984535: Puritan-Bennett 840 Ventilatory System with Bilevel Option, Puritan Bennett Corp. (1998) Summary page 1.

## Most influential descendants
- K040574: Galileo Gold (2004), 53 descendants of its own
- 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

## 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 ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg. The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator 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/K022679
Methodology: https://510kreport.com/methodology