510(k) · Cleared
ClearedIntra.Ox 2.0 Handheld Tissue Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vioptix, Inc. · MUD Oximeter, Tissue Saturation
Cleared on Sep 16, 2019 as substantially equivalent to K163472 (Vioptix, Inc., 2017) after an 84-day review. Its family tree reaches back 6 generations to 1998. 3 later devices descend from it.
- Decided
- Sep 16, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963903 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 5 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 4 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 3 generations backK042657 Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc. · 2005
- 2 generations backK133983 Intra. OX Handheld Tissue OximeterVioptix, Inc. · 2014
- 1 generation backK163472 Intra.Ox Handheld Tissue OximeterVioptix, Inc. · 2017
- This deviceK191676 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK221010 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK233488 Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK250519 Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −5 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −4 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −3 | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | Vioptix, Inc. | 2005 | — |
| −2 | K133983 | Intra. OX Handheld Tissue Oximeter | Vioptix, Inc. | 2014 | — |
| −1 | K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017 | — |
| 0 (this device) | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019 | — |
| +1 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022 | — |
| +2 | K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024 | — |
| +3 | K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | Vioptix, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUD device
- #1 K223651 Cerebral Adaptive Index (CAI) Algorithmscore 19.8 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163472 | Intra.Ox Handheld Tissue OximeterSummary page 5…ode: MUD PAGE 1 OF 7 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] Intra.Ox™ Handheld Tissue Oximeter (K163472) DEVICE DESCRIPTION [807.92(a)(4)] The ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter is a sterile, cordless, battery-powered dev… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K221010 (Vioptix, Inc., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MUD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUD
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUD
131in 2025
MAUDE reports naming product code MUD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 4 | 72 | 0 | 2 |
| 2009 | 4 | 96 | 1 | 7 |
| 2010 | 4 | 59 | 0 | 1 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 6 | 211 | 0 | 3 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 5 | 109 | 0 | 4 |
| 2015 | 3 | 107 | 0 | 0 |
| 2016 | 4 | 167 | 0 | 9 |
| 2017 | 3 | 249 | 0 | 24 |
| 2018 | 3 | 128 | 0 | 38 |
| 2019 | 7 | 88 | 0 | 107 |
| 2020 | 2 | — | 0 | 50 |
| 2021 | 2 | — | 0 | 27 |
| 2022 | 2 | — | 2 | 52 |
| 2023 | 2 | — | 1 | 73 |
| 2024 | 5 | 124 | 0 | 140 |
| 2025 | 2 | — | 0 | 131 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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 ouly be used on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191676: Intra.Ox 2.0 Handheld Tissue Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191676
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026