510(k) Report

510(k) · Cleared

Cleared

Biospectrometer-NB Oximeter Iiii

K963903510(k) TraditionalCleared Jan 27, 1998484-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 27, 1998 after a 484-day review. The FDA summary names no predicate by number. 100 later devices descend from it.

Decided
Jan 27, 1998
Review
484 days
Class
Class II
Product code
MUD
Recalls
None
Predicates
0

100 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2002: 2 descendants cleared2012: 6 descendants cleared2006: 4 descendants cleared2004: 2 descendants cleared2014: 6 descendants cleared2024: 8 descendants cleared2019: 7 descendants cleared2008: 4 descendants cleared2013: 2 descendants cleared2017: 3 descendants cleared2009: 2 descendants cleared2010: 4 descendants cleared2016: 4 descendants cleared2018: 3 descendants cleared2011: 1 descendant cleared2020: 4 descendants cleared2022: 7 descendants cleared2015: 3 descendants cleared2026: 4 descendants cleared2025: 7 descendants cleared2021: 7 descendants cleared2023: 8 descendants cleared1995200020052010201520202025
  1. This deviceK963903 Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc. · 1998
  2. Descendant · cites it directly · 99 of its ownK012759 Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002
  3. Descendant · 2 generations on · 98 of its ownK023938 Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002
  4. Descendant · 2 generations on · 76 of its ownK042020 Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004
  5. Descendant · 3 generations on · 75 of its ownK053618 Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006
  6. Descendant · 3 generations on · 67 of its ownK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2002: 22004: 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 100 · See all
  • K012759Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc. · 2002 · cites it directly99descendants
  • K023938Modification to Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2002 · 2 generations on98descendants
  • K042020Spectra Tissue Spectrometer System (Inspectra)Hutchinson Technology, Inc. · 2004 · 2 generations on76descendants
  • K053618Inspectra Tissue Spectrometer System, Model 325Hutchinson Technology, Inc. · 2006 · 3 generations on75descendants
  • K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004 · 3 generations on67descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
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 K963903, 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?

The FDA summary names no predicate by number.

What descends from it? (100)

See all 100

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

NumberDeviceApplicantDecidedDescendants
K012759Inspectra Tissue Spectrometer System (Inspectra), Model 325Hutchinson Technology, Inc.200299
K042657Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2Vioptix, Inc.20059

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?

  • Of its descendants, K012759 (Hutchinson Technology, Inc., 2002) has gone furthest, with 99 descendants of its own.

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?

The Biospectrometer — NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation:

- in the ear lobe with the 3mm probe

- in the arm, leg, or shoulder with the 15mm probe. 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.

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/K963903 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963903: Biospectrometer-NB Oximeter Iiii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963903

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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