# K181216: Hamilton-T1, Hamilton-C1

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Aug 2, 2019 after 452 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 122 ancestors in all.
No later device cites it as a predicate yet.
15 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140939: Hamilton-T1,Hamilton-C1, Hamilton Medical AG (2015) Summary page 5.

## Recalls of this device
- Jul 26, 2023 · Class I · Z-2525-2023: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead
- Jul 26, 2023 · Class I · Z-2526-2023: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead
- Jul 26, 2023 · Class I · Z-2527-2023: Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead
- Jun 15, 2023 · Class I · Z-2139-2023: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- Jun 15, 2023 · Class I · Z-2140-2023: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

## Indications for use
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of respiratory gases to adults and pediatrics, and optionally infants and neonates. Intended areas of use: * In the intensive care ward, intermediate care ward. emergency ward, long term acute care hospital or in the recovery room * During transfer of ventilated patients within the hospital The HAMILTON-C1 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. The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support or continuous flow of Intended areas of use: « In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room *» For emergency medical care The HAMILTON-T1 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/K181216
Methodology: https://510kreport.com/methodology