510(k) Report

510(k) · Cleared

Cleared

Inspectra Tissue Spectrometer System (Inspectra), Model 325

K012759510(k) TraditionalCleared Jan 17, 2002153-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 Jan 17, 2002 as substantially equivalent to K963903 (Hutchinson Technology, Inc., 1998) after a 153-day review. Its family tree reaches back 1 generation to 1998. 99 later devices descend from it.

Decided
Jan 17, 2002
Review
153 days
Class
Class II
Product code
MUD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963903 (1998). 99 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2012: 6 descendants cleared2002: 1 descendant cleared2006: 4 descendants cleared2005: 2 descendants cleared2004: 2 descendants cleared2014: 6 descendants cleared2024: 8 descendants cleared2019: 7 descendants cleared2008: 4 descendants cleared2013: 2 descendants cleared2009: 2 descendants cleared2010: 4 descendants cleared2016: 4 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2011: 1 descendant cleared2020: 4 descendants cleared2015: 3 descendants cleared2026: 4 descendants cleared2022: 7 descendants cleared2021: 7 descendants cleared2025: 7 descendants cleared2023: 8 descendants clearedK963903 · Biospectrometer-NB Oximeter Iiii · Hutchinson Technology, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 12 descendants3 generations forward: 14 descendants4 generations forward: 8 descendants5 generations forward: 10 descendants6 generations forward: 6 descendants7 generations forward: 8 descendants8 generations forward: 6 descendants9 generations forward: 11 descendants10 generations forward: 13 descendants11 generations forward: 6 descendants K963903 · Biospectrometer-NB Oximeter Iiii · Hutchinson Technology, Inc. · 19980+5+10
  1. Root · 1 generation backK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
  2. This deviceK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
  3. Descendant · cites it directly · 98 of its ownK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
  4. Descendant · cites it directly · 76 of its ownK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
  5. Descendant · 2 generations on · 75 of its ownK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
  6. Descendant · 2 generations on · 67 of its ownK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
  7. Descendant · 3 generations on · 64 of its ownK061619 Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22005: 22006: 42008: 42009: 22010: 42011: 12012: 62013: 22014: 62015: 32016: 42017: 32018: 32019: 72020: 42021: 72022: 72023: 82024: 82025: 72026: 4
2002high 8 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 99 · See all
  • K023938Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002 · cites it directly98descendants
  • 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 · 2 generations on67descendants
  • K061619Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006 · 3 generations on64descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963903Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc.1998—
0 (this device)K012759Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc.2002—
+1K023938Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc.2002—
+1K042020Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc.2004—
+2K053618Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc.2006—
+2K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation2004—
+3K061619Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200520
200640
200840
200920
201040
201110
201260
201320
201460
201530
201640
201730
201830
201970
202040
202170
202270
202380
202480
202570
202640
FIG. 1 — Lineage of K012759, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223651 Cerebral Adaptive Index (CAI) Algorithmscore 19.8 · 29 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K963903Biospectrometer-NB Oximeter Iiii
Summary page 1
…InSpectra™ Tissue Spectrometer System, Model 325 Tissue Spectrometer 21CFR§870.2700 74 MUD Biospectrometer - NB Oximeter, Model 1111 by Hutchinson Technology, Inc. (K963903) This premarket notification (510(K) Notification) is submitted to obtain marketing clearance for the Hutchinson Technology, Inc…
Hutchinson Technology, Inc.1998—

Also cleared against K963903: 1 other device →

What descends from it? (99)

See all 99

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

NumberDeviceApplicantDecidedDescendants
K023938Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc.200298
K042020Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc.200476
K061848Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1Hypermed, Inc.20069
K042657Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc.20059
K113656Careguide OximeterReflectance Medical, Inc.20124

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?

  • Its one ancestor has no recall.
  • Of its descendants, K023938 (Hutchinson Technology, Inc., 2002) has gone furthest, with 98 descendants of its own.
  • 1 other device also cites its predicate K963903.

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

2008: 42009: 42010: 42011: 22012: 62013: 22014: 52015: 32016: 42017: 32018: 32019: 72020: 22021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 7 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUD

124in 2024

2008: 72 days median2009: 96 days median2010: 59 days median2012: 211 days median2014: 109 days median2015: 107 days median2016: 167 days median2017: 249 days median2018: 128 days median2019: 88 days median2024: 124 days median
2007high 249 (2017) · low 59 (2010)2026

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

Recalls per year · MUD

1in 2023

2009: 12022: 22023: 12026 (partial year): 1
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

2008: 22009: 72010: 12011: 22012: 32013: 82014: 42016: 92017: 242018: 382019: 1072020: 502021: 272022: 522023: 732024: 1402025: 131
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
200847202
200949617
201045901
20112—02
2012621103
20132—08
2014510904
2015310700
2016416709
20173249024
20183128038
20197880107
20202—050
20212—027
20222—252
20232—173
202451240140
20252—0131
20261—1—

What is it indicated for?

Hutchinson Technology Incorporated’s InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO,). The InSpectra™ Tissue Spectrometer with 12 to 26 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 InSpectra™…

Read the full statement (103 words)

Hutchinson Technology Incorporated’s InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO,).

The InSpectra™ Tissue Spectrometer with 12 to 26 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 InSpectra™ Tissue 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963903

1 other device cites the same predicate.

  • K042657Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc. · 2005

More from Hutchinson Technology, Inc.

8 FDA decisions under this applicant name. See the company

  • K103613Inpectra STO2 Spot CheckHutchinson Technology, Inc. · 2011
  • K100915Inspectra STO2 Tissue Oxygenation Monitor, Model 650Hutchinson Technology, Inc. · 2010
  • K061619Inspectra STO2 Tissue Oxygenation MonitorHutchinson Technology, Inc. · 2006
  • K053618Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
  • K042020Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004

Recent decisions in MUD

The MUD category page

  • K254129Spectrum-2Neko Health AB · 2026
  • K243324Masimo O3 Regional OximeterMasimo Corporation · 2025
  • K250519Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
  • K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences · 2024
  • K241393ODI-TechOdi Medical AS · 2024

https://510kreport.com/device/K012759 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012759: Inspectra Tissue Spectrometer System (Inspectra), 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/K012759

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026