# K192322: T-Stat 2.0 Microvascular Tissue Oximeter

- Pathway: 510(k) (Special)
- Applicant: Spectros Corporation
- Decided: Sep 23, 2019 after 27 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). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081233: T-Stat 303 Ischemia Monitoring System, Spectros Corporation (2008) Summary page 4.

## Indications for use
The Spectros T-Stat™ 2.0 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states. The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K192322
Methodology: https://510kreport.com/methodology