# K131774: Hamilton-G5

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Oct 9, 2013 after 114 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K902859 (1991). 96 ancestors in all.
10 later devices descend from it; 3 cite it directly.
13 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103803: Hamilton-G5, Hamilton Medical AG (2011) Summary page 1.
- K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585, Maquet Critical Care AB (2008) Summary page 1.

## Most influential descendants
- K161450: Hamilton-C3 (2017), 3 descendants of its own
- K180295: Hamilton-G5 (2019), 2 descendants of its own
- K140939: Hamilton-T1,Hamilton-C1 (2015), 2 descendants of its own
- K201658: Hamilton-C6 (2020), 1 descendant of its own
- K193228: Hamilton-G5 (2020), 1 descendant 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.
- Apr 22, 2014 · Class I · Z-0151-2016: Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected 

## Indications for use
The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. The HAMILTON-G5 ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-G5 ventilator may be used for transport within a hospital or hospital type facility provided compressed gas is supplied. The device is not to be used in the presence of flammable anesthetic agents or other ignition sources. The ventilator is not to be used in an environment with magnetic resonance imaging (MRI) equipment. The device is not intended for transportation outside the hospital or for use in the home environment.

Source page: https://510kreport.com/device/K131774
Methodology: https://510kreport.com/methodology