510(k) · Cleared
ClearedVioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2
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 Jan 10, 2005 as substantially equivalent to K012759 (Hutchinson Technology, Inc., 2002) and 2 other predicates after a 104-day review. Its family tree reaches back 3 generations to 1998. 9 later devices descend from it.
- Decided
- Jan 10, 2005
- Review
- 104 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963903 (1998). 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 2 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 1 generation backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- This deviceK042657 Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK133983 Intra. OX Handheld Tissue OximeterVioptix, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK163472 Intra.Ox Handheld Tissue OximeterVioptix, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK191676 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK221010 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022
- Descendant · 5 generations on · 1 of its ownK233488 Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K133983Intra. OX Handheld Tissue OximeterVioptix, Inc. · 2014 · cites it directly5descendants
- K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. · 2017 · 2 generations on4descendants
- K191676Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019 · 3 generations on3descendants
- K221010Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022 · 4 generations on2descendants
- K233488Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −2 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −1 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| 0 (this device) | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | Vioptix, Inc. | 2005 | — |
| +1 | K133983 | Intra. OX Handheld Tissue Oximeter | Vioptix, Inc. | 2014 | — |
| +2 | K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017 | — |
| +3 | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019 | — |
| +4 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022 | — |
| +5 | K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325Summary page 1…Tissue Spectrometer Classification name: Oximeter The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: K012759 and K023938, InSpectra Tissue Spectrometer System, Model 325, manufactured by Hutchinson Technology Inc. and the… | 2002 |
| * | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325Summary page 1…Tissue Spectrometer Classification name: Oximeter The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: K012759 and K023938, InSpectra Tissue Spectrometer System, Model 325, manufactured by Hutchinson Technology Inc. and the Biospectrome… | 2002 |
| * | K963903 | Biospectrometer-NB Oximeter IiiiSummary page 1…9 and K023938, InSpectra Tissue Spectrometer System, Model 325, manufactured by Hutchinson Technology Inc. and the Biospectrometer NB Oximeter Model 1111 K963903, also manufactured by Hutchinson Technology. Description of the device: The ODISsey Tissue Oximeter is an opt… | 1998 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133983 (Vioptix, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K012759.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042657: Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042657
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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