510(k) · Cleared

Cleared

Modification to Inspectra Tissue Spectrometer System, Model 325

K023938510(k) SpecialCleared Dec 13, 200217-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

Hutchinson Technology, Inc. · MUD Oximeter, Tissue Saturation

Cleared on Dec 13, 2002 as substantially equivalent to K012759 (Hutchinson Technology, Inc., 2002) after a 17-day review. Its family tree reaches back 2 generations to 1998. 98 later devices descend from it.

Decided: Dec 13, 2002
Review: 17 days
Class: Class II
Product code: MUD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K963903 (1998). 98 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
1 generation backK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
This deviceK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
Descendant · cites it directly · 76 of its ownK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
Descendant · 2 generations on · 75 of its ownK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
Descendant · cites it directly · 67 of its ownK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
Descendant · 3 generations on · 64 of its ownK061619 Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006
Descendant · 2 generations on · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2004high 8 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 98 · See all

K042020Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004 · cites it directly76descendants
K053618Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006 · 2 generations on75descendants
K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004 · cites it directly67descendants
K061619Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006 · 3 generations on64descendants
K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005 · 2 generations on63descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K963903	Biospectrometer-NB Oximeter Iiii	Hutchinson Technology, Inc.	1998	—
−1	K012759	Inspectra Tissue Spectrometer System (Inspectra), Model 325	Hutchinson Technology, Inc.	2002	—
0 (this device)	K023938	Modification to Inspectra Tissue Spectrometer System, Model 325	Hutchinson Technology, Inc.	2002	—
+1	K042020	Spectra Tissue Spectrometer System (Inspectra)	Hutchinson Technology, Inc.	2004	—
+2	K053618	Inspectra Tissue Spectrometer System, Model 325	Hutchinson Technology, Inc.	2006	—
+1	K040684	T-Stat Microvascular Tissue Oximeter, Model 303	Spectros Corporation	2004	—
+3	K061619	Inspectra STO2 Tissue Oxygenation Monitor	Hutchinson Technology, Inc.	2006	—
+2	K051257	Adult Cerebral Oximeter, Model 2040	Cas Medical Systems, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	4	0
2008	4	0
2009	2	0
2010	4	0
2011	1	0
2012	6	0
2013	2	0
2014	6	0
2015	3	0
2016	4	0
2017	3	0
2018	3	0
2019	7	0
2020	4	0
2021	7	0
2022	7	0
2023	8	0
2024	8	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K023938, 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? (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	Applicant	Decided	Recalls
*	K012759	Inspectra Tissue Spectrometer System (Inspectra), Model 325	Hutchinson Technology, Inc.	2002	—

Also cleared against K012759: 4 other devices →

What descends from it? (98)

See all 98

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

Number	Device	Applicant	Decided	Descendants
K042020	Spectra Tissue Spectrometer System (Inspectra)	Hutchinson Technology, Inc.	2004	76
K040684	T-Stat Microvascular Tissue Oximeter, Model 303	Spectros Corporation	2004	67
K061848	Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1	Hypermed, Inc.	2006	9
K042657	Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2	Vioptix, Inc.	2005	9

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 4 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K042020 (Hutchinson Technology, Inc., 2004) has gone furthest, with 76 descendants of its own.
4 other devices also cite its predicate K012759.

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?

Hutchinson Technology Incorporated's lnSpectraTMTissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (St02). The lnSpectraTMTissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The…

Read the full statement (100 words)

The lnSpectraTMTissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The lnSpectraTMTissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.

The value of these measurements in disease states has not been demonstrated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023938 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023938: Modification to Inspectra Tissue Spectrometer System, Model 325.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023938

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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