# K102775: Hamilton-C2

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Jan 21, 2011 after 119 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). 67 ancestors in all.
14 later devices descend from it; 2 cite it directly.
13 of 82 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.
- K080181: Modification to Galileo Gold, Hamilton Medical AG (2008) Summary page 1.
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500, Drager Medical AG & Co. Kgaa (2008) Summary page 1.
- K983219: Neoflow Option Model Numbers 8413563, 8411900, Drager, Inc. (1998) Summary page 1.
- K040642: Lpo Option for Drager Intensive Care Ventilator Savina, Draeget Medical AG & Co. Kgaa (2004) Summary page 1.
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E, Maquet Critical Care AB (2004) Summary page 1.

## Most influential descendants
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 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, pediatrics, infants, and neonates. Intended areas of use: * In the intensive care ward or in the recovery room. * During secondary transport from one hospital to another. * 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/K102775
Methodology: https://510kreport.com/methodology