# K163472: Intra.Ox Handheld Tissue Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Vioptix, Inc.
- Decided: Nov 16, 2017 after 339 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 K963903 (1998). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133983: Intra. OX Handheld Tissue Oximeter, Vioptix, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K250519: Lap.Ox™ Laparoscopic Tissue Oximeter (2025), 0 descendants of its own

## Indications for use
The Intra.Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. The Intra.Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations. The Intra.Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.

Source page: https://510kreport.com/device/K163472
Methodology: https://510kreport.com/methodology