510(k) · Cleared
ClearedLap.Ox™ Laparoscopic 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 Jun 26, 2025 as substantially equivalent to K233488 (Vioptix, Inc., 2024) after a 125-day review. Its family tree reaches back 9 generations to 1998.
- Decided
- Jun 26, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963903 (1998). No later device cites it as a predicate yet.
- Root · 9 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 5 generations between
- 3 generations backK191676 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019
- 2 generations backK221010 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022
- 1 generation backK233488 Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024
- This deviceK250519 Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
- 8 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
- 7 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
- 6 generations backK042657 Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc. · 2005
- 5 generations backK133983 Intra. OX Handheld Tissue OximeterVioptix, Inc. · 2014
- 4 generations backK163472 Intra.Ox Handheld Tissue OximeterVioptix, Inc. · 2017
- 3 generations backK191676 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2019
- 2 generations backK221010 Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. · 2022
- 1 generation backK233488 Intra.Ox™ 2.0 Handheld Tissue OximeterVioptix, Inc. · 2024
- This deviceK250519 Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963903 | Biospectrometer-NB Oximeter Iiii | Hutchinson Technology, Inc. | 1998 | — |
| −8 | K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −7 | K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2002 | — |
| −6 | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | Vioptix, Inc. | 2005 | — |
| −5 | K133983 | Intra. OX Handheld Tissue Oximeter | Vioptix, Inc. | 2014 | — |
| −4 | K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017 | — |
| −3 | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019 | — |
| −2 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022 | — |
| −1 | K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024 | — |
| 0 (this device) | K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | Vioptix, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K233488 | Intra.Ox™ 2.0 Handheld Tissue OximeterSummary page 5…MUD Legally Marketed Predicate Devices (21 CFR 807.92(a)(3)) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233488 Intra.Ox Handheld Tissue Oximeter MUD Device Description Summary (21 CFR 807.92(a)(4… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy.
The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy.
The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250519 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250519: Lap.Ox™ Laparoscopic 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/K250519
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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