# K092148: Hamilton-C2

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Mar 4, 2010 after 232 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
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
8 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103803: Hamilton-G5 (2011), 14 descendants of its own
- 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

## Indications for use
The HAMILTON-C2 ventilator is intended to provide positive pressure ventilatory support to adults and paediatrics. Intended areas of use: * In the intensive care ward or in the recovery room. * During transfer of ventilated patients within the hospital. The HAMILTON-C2 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/K092148
Methodology: https://510kreport.com/methodology