# K112006: Hamilton-TC1

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Feb 9, 2012 after 211 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: 11 generations back to K902859 (1991). 82 ancestors in all.
13 later devices descend from it; 2 cite it directly.
14 of 96 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.
- K062267: Oxylog 3000, Drager Medical B.V. (2006) Summary page 1.

## Most influential descendants
- 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
- K120574: Hamilton-C1 (2012), 3 descendants of its own

## Indications for use
The HAMILTON-TC1 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. * For emergency medical care or primary care. * During transport within and outside the hospital. * During transfer by rescue vehicles, jet or helicopter. The HAMILTON-TC1 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/K112006
Methodology: https://510kreport.com/methodology