# K122438: Hamilton-MR1

- Pathway: 510(k) (Abbreviated)
- Applicant: Hamilton Medical AG
- Decided: Nov 20, 2013 after 467 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 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). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator, Impact Instrumentation, Inc. (2012)
- K050055: GE Datex-Ohmeda Aestiva/5 Mri Anesthesia System, Datex-Ohmeda, Inc. (2005) Summary page 1.
- (no number) Hamilton-C1: named in the summary without a submission number

## Most influential descendants
- K153046: Hamilton-MR1 (2016), 0 descendants of its own

## Recalls of this device
- Sep 26, 2016 · Class II · Z-0666-2017: Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.

## Indications for use
The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. intended areas of use: * In the MRI department * In the Intensive care ward 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 T and 3.0 Tesla static magnetic field scanners. The HAMILTON-MR1 ventilator is a restricted 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/K122438
Methodology: https://510kreport.com/methodology