# K161450: Hamilton-C3

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Apr 27, 2017 after 337 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 121 ancestors in all.
3 later devices descend from it; 2 cite it directly.
16 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123637: Hamilton-C3, Hamilton Medical AG (2012) Summary page 4.
- K131774: Hamilton-G5, Hamilton Medical AG (2013) Summary page 4.

## Most influential descendants
- K201658: Hamilton-C6 (2020), 1 descendant of its own
- K252663: Inbentus Versatile (2026), 0 descendants of its own
- K201306: Hamilton-C3 (2021), 0 descendants of its own

## Recalls of this device
- Mar 12, 2018 · Class II · Z-1372-2018: After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
- Mar 9, 2018 · Class II · Z-2796-2018: An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providin

## Indications for use
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Intended areas of use: • In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room • During transfer of ventilated patients within the hospital The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

Source page: https://510kreport.com/device/K161450
Methodology: https://510kreport.com/methodology