# K124061: Mri Patient Monitoring System (Model 865214)

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Feb 22, 2013 after 53 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 29 generations back to K941811 (1994). 194 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090785: Mri Compatible Patient Monitoring System, Model 865214, Invivo Corp. (2009) Summary page 2.

## Most influential descendants
- K152330: Expression MR400 MRI Patient Monitoring System (2015), 2 descendants of its own
- K212271: smart-sync (2022), 0 descendants of its own
- K182900: 3880 MRI Patient Monitoring System (2018), 0 descendants of its own
- K132359: Mri Patient Monitoring System (2013), 0 descendants of its own

## Recalls of this device
- Jun 17, 2015 · Class II · Z-2266-2015: The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The ap

## Indications for use
The MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

Source page: https://510kreport.com/device/K124061
Methodology: https://510kreport.com/methodology