510(k) · Cleared
ClearedOxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hypermed, Inc. · MUD Oximeter, Tissue Saturation
Cleared on Jan 25, 2008 as substantially equivalent to K061848 (Hypermed, Inc., 2006) after a 30-day review. Its family tree reaches back 6 generations to 1998. 8 later devices descend from it.
- Decided
- Jan 25, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- MUD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963903 (1998). 8 later devices descend from it, 3 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 backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
- 2 generations backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
- 1 generation backK061848 Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1Hypermed, Inc. · 2006
- This deviceK073656 Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK113507 Kent CameraKent Imaging, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK153426 Ox-Imager CSModulated Imaging, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK181623 Clarifi Imaging SystemModulated Imaging, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK163070 Kent CameraKent Imaging, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK254129 Spectrum-2Neko Health AB · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K113507Kent CameraKent Imaging, Inc. · 2012 · cites it directly3descendants
- K153426Ox-Imager CSModulated Imaging, Inc. · 2016 · cites it directly2descendants
- K181623Clarifi Imaging SystemModulated Imaging, Inc. · 2018 · 2 generations on1descendant
- K163070Kent CameraKent Imaging, Inc. · 2017 · 2 generations on1descendant
- K254129Spectrum-2Neko Health AB · 2026 · 3 generations on0descendants
View 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 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | — |
| −2 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | — |
| −1 | K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 | Hypermed, Inc. | 2006 | — |
| 0 (this device) | K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System | Hypermed, Inc. | 2008 | — |
| +1 | K113507 | Kent Camera | Kent Imaging, Inc. | 2012 | — |
| +1 | K153426 | Ox-Imager CS | Modulated Imaging, Inc. | 2016 | — |
| +2 | K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | 2018 | — |
| +2 | K163070 | Kent Camera | Kent Imaging, Inc. | 2017 | — |
| +3 | K254129 | Spectrum-2 | Neko Health AB | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1Summary page 1…Product Code: MUD Substantial Equivalence The OxyVuTM-I system is substantially equivalent to the OxyVuTM-I system cleared in 5 10(k) K061848. Device Description The OxyVuTM-1 system is based on hyperspectral imaging technology. The technology performs… | 2006 |
What descends from it? (8)
3 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 10 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K113507 (Kent Imaging, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K061848.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 OxyVuTM-l Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
• oxygen saturation (HT-Sat),
* oxyhemoglobin level (HT-Oxy), and
· deoxyhemoglobin (HT-Deoxy) level
in superficial tissue. The OxyVuTM-1 system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The OxyVuTM-I system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073656 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073656: Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073656
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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