# K103803: Hamilton-G5

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Nov 23, 2011 after 330 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K902859 (1991). 91 ancestors in all.
14 later devices descend from it; 3 cite it directly.
15 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092148: Hamilton-C2, Hamilton Medical AG (2010) Summary page 1.
- K080181: Modification to Galileo Gold, Hamilton Medical AG (2008)
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500, Drager Medical AG & Co. Kgaa (2008) Summary page 1.
- K983219: Neoflow Option Model Numbers 8413563, 8411900, Drager, Inc. (1998) Summary page 1.
- K092733: PYTON, Arm Medical Devices, Inc. (2010) Summary page 1.
- K081842: Engstrom Carestation, Engstrom Pro, Datex-Ohmeda, Inc. (2008) Summary page 1.

## Most influential descendants
- K131774: Hamilton-G5 (2013), 10 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K123637: Hamilton-C3 (2012), 4 descendants of its own
- K161450: Hamilton-C3 (2017), 3 descendants of its own
- K180295: Hamilton-G5 (2019), 2 descendants of its own

## Recalls of this device
- Mar 25, 2019 · Class I · Z-1874-2019: New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patien
- Mar 9, 2016 · Class II · Z-1624-2016: After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
- Mar 24, 2015 · Class II · Z-2057-2015: Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
- Feb 6, 2012 · Not classified · Z-1185-2012: Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.

## Indications for use
The HAMILTON-G5 ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside 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/K103803
Methodology: https://510kreport.com/methodology