# K040684: T-Stat Microvascular Tissue Oximeter, Model 303

- Pathway: 510(k) (Traditional)
- Applicant: Spectros Corporation
- Decided: Nov 5, 2004 after 234 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: 5 generations back to K931154 (1993). 19 ancestors in all.
67 later devices descend from it; 7 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325, Hutchinson Technology, Inc. (2002) Summary page 2.
- K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100, Somanetics Corp. (2000) Summary page 2.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 2.
- K011869: Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment, The Olympus Optical Co. (2001) Summary page 2.
- K002231: LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary Equipment, Olympus Optical Co., Ltd. (2001) Summary page 2.
- K915857: Flexible Tip Thoracoscope/Laparoscope, Olympus Corp. (1994) Summary page 2.

## Most influential descendants
- K051257: Adult Cerebral Oximeter, Model 2040 (2005), 63 descendants of its own
- K073036: Fore-Sight, MC-2000 Series (2008), 59 descendants of its own
- K061960: Fore-Sight Cerebral Oximeter Monitor, Model 2040 (2006), 59 descendants of its own
- K083892: Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) (2009), 58 descendants of its own
- K091452: Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) (2009), 57 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 TStatTM Oximeter has not been demonstrated in disease states. The T-StatTM Oximeter should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K040684
Methodology: https://510kreport.com/methodology