510(k) Report

510(k) · Cleared

Cleared

Invos Cerebral/Somatic Oximeter System, Model: 5100C

K082327510(k) TraditionalCleared Apr 3, 2009232-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 Apr 3, 2009 as substantially equivalent to K080769 (Somanetics Corp., 2008) after a 232-day review. Its family tree reaches back 3 generations to 2000. 66 later devices descend from it.

Decided
Apr 3, 2009
Review
232 days
Class
Class II
Product code
MUD
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001842 (2000). 66 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared2018: 2 descendants cleared2011: 1 descendant cleared2021: 8 descendants cleared2009: 2 descendants cleared2015: 4 descendants cleared2019: 5 descendants cleared2017: 1 descendant cleared2012: 2 descendants cleared2016: 3 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2020: 3 descendants cleared2022: 6 descendants cleared2024: 6 descendants cleared2023: 8 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. · 2008200020052010201520202025
Descendants, by generation 1 generation forward: 10 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 7 descendants5 generations forward: 7 descendants6 generations forward: 11 descendants7 generations forward: 13 descendants8 generations forward: 7 descendants K080769 · 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 · 3 generations backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
  2. 2 generations backK051274 Invos SystemSomanetics Corp. · 2005
  3. 1 generation backK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  4. This deviceK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  5. Descendant · cites it directly · 57 of its ownK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
  6. Descendant · cites it directly · 53 of its ownK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010
  7. Descendant · 2 generations on · 53 of its ownK102715 Regional OximeterNonin Medical, Inc. · 2010
  8. Descendant · cites it directly · 49 of its ownK091224 Oxyalert Nirsensors, Accessories for Invos 5100C System, Models…Somanetics Corp. · 2009
  9. Descendant · 2 generations on · 47 of its ownK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2009: 22010: 32011: 12012: 22013: 12014: 22015: 42016: 32017: 12018: 22019: 52020: 32021: 82022: 62023: 82024: 62025: 62026: 3
2009high 8 (2021) · low 1 (2011)2026

Most influential descendants

Showing 5 of 66 · See all
  • K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009 · cites it directly57descendants
  • K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc. · 2010 · cites it directly53descendants
  • K102715Regional OximeterNonin Medical, Inc. · 2010 · 2 generations on53descendants
  • K091224Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSomanetics Corp. · 2009 · cites it directly49descendants
  • K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012 · 2 generations on47descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
−2K051274Invos SystemSomanetics Corp.2005—
−1K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp.2008—
0 (this device)K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp.2009—
+1K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.2009—
+1K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models…Cas Medical Systems, Inc.2010—
+2K102715Regional OximeterNonin Medical, Inc.2010—
+1K091224Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSomanetics Corp.2009—
+2K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201030
201110
201220
201310
201420
201540
201630
201710
201820
201950
202030
202180
202260
202380
202460
202560
202630
FIG. 1 — Lineage of K082327, 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
*K080769Invos Cerebral/Somatic Oximeter System, Model 5100C
Summary page 1
…evice: ......................................... Somanetics INVOS 5100C Cerebral/Somatic Oximeter System, K080769 Device Description: ....................................... The INVOS 5 1OOC is a 2 wavelength, diffuse…
Somanetics Corp.2008—

Also cleared against K080769: 4 other devices →

What descends from it? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957
K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053
K091224Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSomanetics Corp.200949
K182868INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorCovidien, LLC20191
K143219Niro-200NXHamamatsu Photonics K.K.20151
K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional…Covidien, LLC20210
K182242VO200 – NeurOs Cerebral Oximetry SystemMespere Lifesciences, Inc.20180
K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170
K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center…Midwest Reprocessing Center, LLC20110
K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…Hygia Health Services, Inc.20100

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 3 ancestors has a recall.
  • Of its descendants, K091452 (Cas Medical Systems, Inc., 2009) has gone furthest, with 57 descendants of its own.
  • 4 other devices also cite its predicate K080769.

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. The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

Indications for use as stated in the FDA summary.

Also cleared against K080769

4 other devices cite the same predicate.

  • K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax…Midwest Reprocessing Center, LLC · 2011
  • K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM…Hygia Health Services, Inc. · 2010
  • K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
  • K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009

More from Somanetics Corp.

12 FDA decisions under this applicant name. See the company

  • K093422Vital Sync Model 5000 SeriesSomanetics Corp. · 2010
  • K091224Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSomanetics 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/K082327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082327

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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