510(k) · Cleared
ClearedIntra.Ox 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 Nov 16, 2017 as substantially equivalent to K133983 (Vioptix, Inc., 2014) after a 339-day review. Its family tree reaches back 5 generations to 1998. 4 later devices descend from it.
- Decided
- Nov 16, 2017
- Review
- 339 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963903 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 4 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 3 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 2 generations backK042657 Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc. · 2005
- 1 generation backK133983 Intra. OX Handheld Tissue OximeterVioptix, Inc. · 2014
- This deviceK163472 Intra.Ox Handheld Tissue OximeterVioptix, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK191676 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK221010 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK233488 Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK250519 Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K191676Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019 · cites it directly3descendants
- K221010Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022 · 2 generations on2descendants
- K233488Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024 · 3 generations on1descendant
- K250519Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −4 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −3 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −2 | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | Vioptix, Inc. | 2005 | — |
| −1 | K133983 | Intra. OX Handheld Tissue Oximeter | Vioptix, Inc. | 2014 | — |
| 0 (this device) | K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017 | — |
| +1 | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019 | — |
| +2 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022 | — |
| +3 | K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024 | — |
| +4 | K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | Vioptix, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K133983 | Intra. OX Handheld Tissue OximeterSummary page 4…Trade Name: Intra.Ox™ Handheld Tissue Oximeter Generic/Common Name: Oximeter, Tissue Saturation PREDICATE DEVICE(S) [807.92(A)(3)] Intra.Ox™ Handheld Tissue Oximeter (K133983) Page 1 of 6 K163472 510(k)… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | 2019 | 3 |
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 19 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191676 (Vioptix, Inc., 2019) has gone furthest, with 3 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. 2017, 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.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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163472: Intra.Ox Handheld Tissue Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163472
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