# K221010: Intra.Ox 2.0 Handheld Tissue Oximeter

- Pathway: 510(k) (Special)
- Applicant: Vioptix, Inc.
- Decided: May 3, 2022 after 28 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.
2 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)
- K191676: Intra.Ox 2.0 Handheld Tissue Oximeter, Vioptix, Inc. (2019) Summary page 4.

## Most influential descendants
- 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.OxTM 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. The Intra.OxTM 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations. The Intra.OxTM 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Intra.OxTM 2.0 Handheld Tissue Oximeter should only be used on adult patients.

Source page: https://510kreport.com/device/K221010
Methodology: https://510kreport.com/methodology