# K120574: Hamilton-C1

- Pathway: 510(k) (Abbreviated)
- Applicant: Hamilton Medical AG
- Decided: May 30, 2012 after 93 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: 12 generations back to K902859 (1991). 83 ancestors in all.
3 later devices descend from it; 1 cites it directly.
9 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112006: Hamilton-TC1, Hamilton Medical AG (2012) Summary page 1.

## Most influential descendants
- K140939: Hamilton-T1,Hamilton-C1 (2015), 2 descendants of its own
- K181216: Hamilton-T1, Hamilton-C1 (2019), 0 descendants of its own
- K153046: Hamilton-MR1 (2016), 0 descendants of its own

## Indications for use
The HAMILTON-Cl ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Intended areas of use: * In the intensive care ward or in the recovery room. * During transfer of ventilated patients within the hospital. The HAMILTON-Cl 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/K120574
Methodology: https://510kreport.com/methodology