510(k) · Cleared
ClearedSpectrum-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neko Health AB · MUD Oximeter, Tissue Saturation
Cleared on May 22, 2026 as substantially equivalent to K181623 (Modulated Imaging, Inc., 2018) after a 151-day review. Its family tree reaches back 9 generations to 1998.
- Decided
- May 22, 2026
- Review
- 151 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 backK073656 Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc. · 2008
- 2 generations backK153426 Ox-Imager CSModulated Imaging, Inc. · 2016
- 1 generation backK181623 Clarifi Imaging SystemModulated Imaging, Inc. · 2018
- This deviceK254129 Spectrum-2Neko Health AB · 2026
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 backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
- 5 generations backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
- 4 generations backK061848 Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1Hypermed, Inc. · 2006
- 3 generations backK073656 Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc. · 2008
- 2 generations backK153426 Ox-Imager CSModulated Imaging, Inc. · 2016
- 1 generation backK181623 Clarifi Imaging SystemModulated Imaging, Inc. · 2018
- This deviceK254129 Spectrum-2Neko Health AB · 2026
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 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | — |
| −5 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | — |
| −4 | K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 | Hypermed, Inc. | 2006 | — |
| −3 | K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System | Hypermed, Inc. | 2008 | — |
| −2 | K153426 | Ox-Imager CS | Modulated Imaging, Inc. | 2016 | — |
| −1 | K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | 2018 | — |
| 0 (this device) | K254129 | Spectrum-2 | Neko Health AB | 2026 | — |
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 |
|---|---|---|---|
| * | K181623 | Clarifi Imaging SystemSummary page 6…ally Marketed Predicate Device 1.3.1 Clarifi Imaging System The primary predicate device for the Spectrum-2 is the Clarifi Imaging System cleared under K181623. 510(k) Number K181623 Trade Name: Clarifi Imaging System Common Name:… | 2018 |
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 28 years and passes through 4 companies; a new generation was cleared every 1.6 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. 2026, 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 Spectrum-2 device is indicated for use to record and monitor changes in oxygenation levels in superficial tissues during circulatory or perfusion examinations for individuals with potential circulatory compromise.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254129: Spectrum-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254129
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026