# K042657: Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2

- Pathway: 510(k) (Traditional)
- Applicant: Vioptix, Inc.
- Decided: Jan 10, 2005 after 104 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: 3 generations back to K963903 (1998). 3 ancestors in all.
9 later devices descend from it; 4 cite 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)
- K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325, Hutchinson Technology, Inc. (2002) Summary page 1.
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325, Hutchinson Technology, Inc. (2002) Summary page 1.
- K963903: Biospectrometer-NB Oximeter Iiii, Hutchinson Technology, Inc. (1998) Summary page 1.

## Most influential descendants
- K133983: Intra. OX Handheld Tissue Oximeter (2014), 5 descendants of its own
- K163472: Intra.Ox Handheld Tissue Oximeter (2017), 4 descendants of its own
- K191676: Intra.Ox 2.0 Handheld Tissue Oximeter (2019), 3 descendants of its own
- K221010: Intra.Ox 2.0 Handheld Tissue Oximeter (2022), 2 descendants of its own
- K233488: Intra.Ox™ 2.0 Handheld Tissue Oximeter (2024), 1 descendant of its own

## Indications for use
The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services. The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Source page: https://510kreport.com/device/K042657
Methodology: https://510kreport.com/methodology