# K081233: T-Stat 303 Ischemia Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Spectros Corporation
- Decided: Jul 28, 2008 after 88 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: 6 generations back to K931154 (1993). 20 ancestors in all.
56 later devices descend from it; 3 cite it directly.
0 of 77 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.

## Most influential descendants
- K094030: Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000, MC2010, MC2020, MC2030 (2010), 53 descendants of its own
- K112820: Fore-Sight Absolute Tissue Oximeter (2012), 47 descendants of its own
- K133879: Fore-Sight Elite Absolute Tissue Oximeter (2014), 44 descendants of its own
- K113215: Model 7600 Regional Oximeter System with Equanox Technology (2012), 42 descendants of its own
- K143675: FORE-SIGHT Elite Absolute Tissue Oximeter (2015), 37 descendants of its own

## Indications for use
The Spectros T-StatTM 303 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO 2%) 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-StatTM Oximeter has not been demonstrated in disease states. The T-Stat MT Oximeter should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K081233
Methodology: https://510kreport.com/methodology