510(k) · Cleared
Recalled · Class II · 2023SnapshotNIR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kent Imaging · MUD Oximeter, Tissue Saturation
Cleared on Nov 10, 2020 as substantially equivalent to K163070 (Kent Imaging, Inc., 2017) after a 117-day review. Its family tree reaches back 9 generations to 1998. It has been recalled once.
- Decided
- Nov 10, 2020
- Review
- 117 days
- Class
- Class II
- Product code
- MUD
- Recalls
- 1
- 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 backK113507 Kent CameraKent Imaging, Inc. · 2012
- 1 generation backK163070 Kent CameraKent Imaging, Inc. · 2017
- This deviceK201976 SnapshotNIRKent Imaging · 2020
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 backK113507 Kent CameraKent Imaging, Inc. · 2012
- 1 generation backK163070 Kent CameraKent Imaging, Inc. · 2017
- This deviceK201976 SnapshotNIRKent Imaging · 2020
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 | K113507 | Kent Camera | Kent Imaging, Inc. | 2012 | — |
| −1 | K163070 | Kent Camera | Kent Imaging, Inc. | 2017 | — |
| 0 (this device) | K201976 | SnapshotNIR | Kent Imaging | 2020 | — |
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 |
|---|---|---|---|
| * | K163070 | Kent CameraSummary page 4…Class II Classification Panel: Cardiovascular Device Description SnapshotNIR, Model KD204 (K201976), is a modification to the Kent Camera, Model KD203 (K163070). The changes made to create the modified snapshot include modifications to the software. Both devices have similar hardware. Sna… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2023 | Class II | Z-0789-2024 | Nonconforming Material/Component | Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.8 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. 2020, 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?
SnapshotNIR is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (St02),
- relative oxyhemogoblin level (Hb02), and
- relative deoxyhemoglobin (Hb) level
in superficial tissue. SnapshotNIR displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions.
SnapshotNIR is indicated for use to determine oxygenation levels in superficial tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201976: SnapshotNIR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201976
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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