510(k) Report

510(k) · Cleared

Cleared

Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S

K091224510(k) SpecialCleared Jul 9, 200973-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

Somanetics Corp. · MUD Oximeter, Tissue Saturation

Cleared on Jul 9, 2009 as substantially equivalent to K082327 (Somanetics Corp., 2009) after a 73-day review. Its family tree reaches back 4 generations to 2000. 49 later devices descend from it.

Decided
Jul 9, 2009
Review
73 days
Class
Class II
Product code
MUD
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K001842 (2000). 49 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2021: 8 descendants cleared2012: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2019: 3 descendants cleared2022: 6 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2023: 8 descendants cleared2024: 5 descendants cleared2025: 6 descendants cleared2026: 3 descendants clearedK001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 2000K051274 · Invos System · Somanetics Corp. · 2005K080769 · Invos Cerebral/Somatic Oximeter System, Model 5100C · Somanetics Corp. · 2008K082327 · Invos Cerebral/Somatic Oximeter System, Model: 5100C · Somanetics Corp. · 2009200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 7 descendants5 generations forward: 11 descendants6 generations forward: 13 descendants7 generations forward: 7 descendants K082327 · Invos Cerebral/Somatic Oximeter System, Model: 5100C · Somanetics Corp. · 2009K080769 · Invos Cerebral/Somatic Oximeter System, Model 5100C · Somanetics Corp. · 2008K051274 · Invos System · Somanetics Corp. · 2005K001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 20000+5
  1. Root · 4 generations backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
  2. 3 generations backK051274 Invos SystemSomanetics Corp. · 2005
  3. 2 generations backK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  4. 1 generation backK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  5. This deviceK091224 Oxyalert Nirsensors, Accessories for Invos 5100C System, Models…Somanetics Corp. · 2009
  6. Descendant · cites it directly · 47 of its ownK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
  7. Descendant · 2 generations on · 44 of its ownK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
  8. Descendant · 2 generations on · 37 of its ownK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
  9. Descendant · 3 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
  10. Descendant · 3 generations on · 29 of its ownK180003 FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12015: 22016: 12017: 12018: 12019: 32020: 22021: 82022: 62023: 82024: 52025: 62026: 3
2012high 8 (2021) · low 1 (2012)2026

Most influential descendants

Showing 5 of 49 · See all
  • K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012 · cites it directly47descendants
  • K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014 · 2 generations on44descendants
  • K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · 2 generations on37descendants
  • K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 3 generations on34descendants
  • K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc. · 2018 · 3 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
−3K051274Invos SystemSomanetics Corp.2005—
−2K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp.2008—
−1K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp.2009—
0 (this device)K091224Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSomanetics Corp.2009—
+1K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.2012—
+2K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.2014—
+2K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.20151
+3K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC2019—
+3K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.20181

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201520
201610
201710
201810
201930
202020
202180
202260
202380
202450
202560
202630
FIG. 1 — Lineage of K091224, 2000–2026Source: 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
*K082327Invos Cerebral/Somatic Oximeter System, Model: 5100C
Summary page 1
…rwidman~somanetics.com Predicate Device:.......................Somanetics lNVOS 5 l OOC Cerebral/Somatic Oximeter System, K082327 Accessories ........................... SAFB-SM Small Adult SomaSensor (>40 kg)…
Somanetics Corp.2009—

Also cleared against K082327: 9 other devices →

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247
K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional…Covidien, LLC20210

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 9 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K112820 (Cas Medical Systems, Inc., 2012) has gone furthest, with 47 descendants of its own.
  • 9 other devices also cite its predicate K082327.

How does its category compare?

All MUD devices

MUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 noninvasive INVOS 5100C is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual.

Indications for use as stated in the FDA summary.

Also cleared against K082327

9 other devices cite the same predicate.

  • K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also…Covidien, LLC · 20211 recall
  • K182868INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorCovidien, LLC · 20191 recall
  • K182242VO200 – NeurOs Cerebral Oximetry SystemMespere Lifesciences, Inc. · 2018
  • K162603Masimo O3 Regional Oximeter SystemMasimo Corporation · 2017
  • K143219Niro-200NXHamamatsu Photonics K.K. · 2015
  • K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax…Midwest Reprocessing Center, LLC · 2011

More from Somanetics Corp.

12 FDA decisions under this applicant name. See the company

  • K093422Vital Sync Model 5000 SeriesSomanetics Corp. · 2010
  • K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  • K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  • K051274Invos SystemSomanetics Corp. · 2005
  • K040162Correstore Patch SystemSomanetics Corp. · 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/K091224 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091224: Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091224

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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