# K121225: Hamilton-C2

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Nov 16, 2012 after 207 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K902859 (1991). 114 ancestors in all.
8 later devices descend from it; 2 cite it directly.
17 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102775: Hamilton-C2, Hamilton Medical AG (2011) Summary page 1.
- K103803: Hamilton-G5, Hamilton Medical AG (2011) Summary page 1.
- K120670: Hamilton-T1, Hamilton Medical AG (2012) Summary page 1.
- K093632: Infinity Acute Care System Workstation Neonatal Care, Drager Medical AG & Co. Kgaa (2010) Summary page 1.

## Most influential descendants
- K123637: Hamilton-C3 (2012), 4 descendants of its own
- K161450: Hamilton-C3 (2017), 3 descendants of its own
- K140939: Hamilton-T1,Hamilton-C1 (2015), 2 descendants of its own
- K201658: Hamilton-C6 (2020), 1 descendant of its own
- K252663: Inbentus Versatile (2026), 0 descendants of its own

## Recalls of this device
- Jun 15, 2023 · Class I · Z-2141-2023: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- Mar 12, 2018 · Class II · Z-1371-2018: After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
- Sep 26, 2013 · Class II · Z-0170-2014: Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.

## Indications for use
The HAMILTON-C2 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates. 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/K121225
Methodology: https://510kreport.com/methodology