510(k) · Cleared

Cleared

Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1

K061848510(k) TraditionalCleared Nov 8, 2006131-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hypermed, Inc. · MUD Oximeter, Tissue Saturation

Cleared on Nov 8, 2006 as substantially equivalent to K053618 (Hutchinson Technology, Inc., 2006) and 3 other predicates after a 131-day review. Its family tree reaches back 5 generations to 1998. 9 later devices descend from it.

Decided: Nov 8, 2006
Review: 131 days
Class: Class II
Product code: MUD
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K963903 (1998). 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 5 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
4 generations backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
3 generations backK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
2 generations backK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
1 generation backK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
This deviceK061848 Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1Hypermed, Inc. · 2006
Descendant · cites it directly · 8 of its ownK073656 Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc. · 2008
Descendant · cites it directly · 3 of its ownK113507 Kent CameraKent Imaging, Inc. · 2012
Descendant · 2 generations on · 2 of its ownK153426 Ox-Imager CSModulated Imaging, Inc. · 2016
Descendant · 3 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

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 2 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all

K073656Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemHypermed, Inc. · 2008 · cites it directly8descendants
K113507Kent CameraKent Imaging, Inc. · 2012 · cites it directly3descendants
K153426Ox-Imager CSModulated Imaging, Inc. · 2016 · 2 generations on2descendants
K181623Clarifi Imaging SystemModulated Imaging, Inc. · 2018 · 3 generations on1descendant
K163070Kent CameraKent Imaging, Inc. · 2017 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K963903	Biospectrometer-NB Oximeter Iiii	Hutchinson Technology, Inc.	1998	—
−4	K012759	Inspectra Tissue Spectrometer System (Inspectra), Model 325	Hutchinson Technology, Inc.	2002	—
−3	K023938	Modification to Inspectra Tissue Spectrometer System, Model 325	Hutchinson Technology, Inc.	2002	—
−2	K042020	Spectra Tissue Spectrometer System (Inspectra)	Hutchinson Technology, Inc.	2004	—
−1	K053618	Inspectra Tissue Spectrometer System, Model 325	Hutchinson Technology, Inc.	2006	—
0 (this device)	K061848	Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1	Hypermed, Inc.	2006	—
+1	K073656	Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System	Hypermed, Inc.	2008	—
+1	K113507	Kent Camera	Kent Imaging, Inc.	2012	—
+2	K153426	Ox-Imager CS	Modulated Imaging, Inc.	2016	—
+3	K181623	Clarifi Imaging System	Modulated Imaging, Inc.	2018	—
+2	K163070	Kent Camera	Kent Imaging, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2012	1	0
2016	2	0
2017	1	0
2018	2	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K061848, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K053618	Inspectra Tissue Spectrometer System, Model 325 Summary page 1 …ly equivalent to the Inspectra Tissue Spectrometer System, Model 325 manufactured by Hutchinson Technology, Inc. The Inspectra system was cleared in 510(k)'s K053618, K042020, K023938, and K012759. Device Description The OxyVu- 1 system is based on hyperspectral imaging technology…	Hutchinson Technology, Inc.	2006	—
*	K042020	Spectra Tissue Spectrometer System (Inspectra) Summary page 1 …lent to the Inspectra Tissue Spectrometer System, Model 325 manufactured by Hutchinson Technology, Inc. The Inspectra system was cleared in 510(k)'s K053618, K042020, K023938, and K012759. Device Description The OxyVu- 1 system is based on hyperspectral imaging technology. The T…	Hutchinson Technology, Inc.	2004	—
*	K023938	Modification to Inspectra Tissue Spectrometer System, Model 325 Summary page 1 …he Inspectra Tissue Spectrometer System, Model 325 manufactured by Hutchinson Technology, Inc. The Inspectra system was cleared in 510(k)'s K053618, K042020, K023938, and K012759. Device Description The OxyVu- 1 system is based on hyperspectral imaging technology. The Traditiona…	Hutchinson Technology, Inc.	2002	—
*	K012759	Inspectra Tissue Spectrometer System (Inspectra), Model 325 Summary page 1 …Spectrometer System, Model 325 manufactured by Hutchinson Technology, Inc. The Inspectra system was cleared in 510(k)'s K053618, K042020, K023938, and K012759. Device Description The OxyVu- 1 system is based on hyperspectral imaging technology. The Traditional 510(k)…	Hutchinson Technology, Inc.	2002	—

Also cleared against K053618: 2 other devices →

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073656	Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System	Hypermed, Inc.	2008	8
K113507	Kent Camera	Kent Imaging, Inc.	2012	3

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 8 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K073656 (Hypermed, Inc., 2008) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K053618.

How does its category compare?

All MUD devices

MUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUD

2in 2025

2007high 7 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUD

124in 2024

2007high 249 (2017) · low 59 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUD

1in 2023

2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUD

131in 2025

2007high 140 (2024) · low 0 (2007)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 OxyVu-1 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 OxyVu- I 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 OxyVu- 1 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/K061848 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061848: Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061848

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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