# K193228: Hamilton-G5

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: May 4, 2020 after 164 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: 14 generations back to K902859 (1991). 98 ancestors in all.
1 later device descends from it; 1 cites it directly.
9 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180295: Hamilton-G5, Hamiton Medical AG (2019) Summary page 4.

## Most influential descendants
- K231778: Nihon Kohden NKV-550 Series Ventilator System (2024), 0 descendants of its own

## Indications for use
The HAMILTON-GS 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-GS ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The HAMILTON-GS 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/K193228
Methodology: https://510kreport.com/methodology