# K103613: Inpectra STO2 Spot Check

- Pathway: 510(k) (Traditional)
- Applicant: Hutchinson Technology, Inc.
- Decided: Mar 2, 2011 after 83 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 K963903 (1998). 7 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100915: Inspectra STO2 Tissue Oxygenation Monitor, Model 650, Hutchinson Technology, Inc. (2010) Summary page 1.

## Most influential descendants
- K113656: Careguide Oximeter (2012), 4 descendants of its own
- K122645: Mobile Careguide 2100 Oximeter (2012), 3 descendants of its own
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter (2013), 2 descendants of its own
- K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet (2014), 1 descendant of its own
- K141496: Multi-Parameter Mobile Careguide 4100 Oximeter (2014), 0 descendants of its own

## Indications for use
Hutchinson Technology Incorporated's InSpectra StO₂ Spot Check is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO₂). The InSpectra StO₂ Spot Check is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.

Source page: https://510kreport.com/device/K103613
Methodology: https://510kreport.com/methodology