# K112826: Noorvms-Oxy Tissue Oxygen and Temperture Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Moor Instruments, Ltd.
- Decided: Oct 10, 2012 after 378 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303, Spectros Corporation (2004) Summary page 1.
- K081233: T-Stat 303 Ischemia Monitoring System, Spectros Corporation (2008) Summary page 1.
- K083082: Moorvms-LDF1 and Moorvms-LDF2 Laser Doppler Perfusion and Temperature Monitors, Moor Instruments, Ltd. (2009) Summary page 1.

## Indications for use
The moorVMS-OXY monitor is a non-invasive monitoring system that measures tissue oxygen saturation and tissue temperature in microcirculation. It is intended to noninvasively and continuously measure approximated value of hemoglobin oxygen saturation in superficial tissues for clinical research applications. The clinical value of measurements in disease states has not been demonstrated. The moorVMS-OXY monitor should not be used as the sole basis for diagnosis or therapy. The moorVMS-OXY monitor can also be used for the simultaneous measurement of tissue oxygen saturation and blood flow in microcirculation using a combined probe in conjunction with a moorVMS-LDF laser Doppler blood flow monitor.

Source page: https://510kreport.com/device/K112826
Methodology: https://510kreport.com/methodology