# K120670: Hamilton-T1

- Pathway: 510(k) (Special)
- Applicant: Hamilton Medical AG
- Decided: Apr 3, 2012 after 29 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- 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.
11 later devices descend from it; 3 cite it directly.
14 of 95 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
- 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
- K140939: Hamilton-T1,Hamilton-C1 (2015), 2 descendants of its own
- K201658: Hamilton-C6 (2020), 1 descendant of its own

## Recalls of this device
- Dec 19, 2012 · Class I · Z-0741-2013: Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator w

## Indications for use
The HAMILTON-Ti 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-Ti 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/K120670
Methodology: https://510kreport.com/methodology