510(k) · Cleared
ClearedODI-Tech
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odi Medical AS · MUD Oximeter, Tissue Saturation
Cleared on Aug 30, 2024 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 30, 2024
- Review
- 106 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the dorsum of the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only. The clinical value of trend data has not been demonstrated in disease…
Read the full statement (121 words)
The noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the dorsum of the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only.
The clinical value of trend data has not been demonstrated in disease states.
The ODI-Tech device should not be used as the sole basis for diagnosis or therapy.
In patients with darkly pigmented skin, measurements should be interpreted with caution, as melanin can interfere with the reflected light signal and reduce the quality of measurements.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K241393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241393: ODI-Tech.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026