# K090468: Hamilton-C2

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Jun 15, 2009 after 112 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: 10 generations back to K902859 (1991). 56 ancestors in all.
No later device cites it as a predicate yet.
6 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081521: Modification to Hamilton-G5, Hamilton Medical AG (2008) Summary page 1.
- K023289: Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072, Drager Medizintechnik GmbH (2003) Summary page 1.

## 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 restricted 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/K090468
Methodology: https://510kreport.com/methodology