# K153046: Hamilton-MR1

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Sep 6, 2016 after 323 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: 15 generations back to K902859 (1991). 138 ancestors in all.
No later device cites it as a predicate yet.
16 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122438: Hamilton-MR1, Hamilton Medical AG (2013) Summary page 4.
- K140939: Hamilton-T1,Hamilton-C1, Hamilton Medical AG (2015) Summary page 4.

## Recalls of this device
- Jul 26, 2023 · Class I · Z-2528-2023: 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

## Indications for use
The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Intended areas of use: • In the MRI department • 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-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners. The HAMILTON-MR1 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/K153046
Methodology: https://510kreport.com/methodology