510(k) Report

510(k) · Cleared

Cleared

Invos System

K051274510(k) TraditionalCleared Nov 4, 2005171-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 Nov 4, 2005 as substantially equivalent to K001842 (Somanetics Corp., 2000) after a 171-day review. Its family tree reaches back 1 generation to 2000. 76 later devices descend from it.

Decided
Nov 4, 2005
Review
171 days
Class
Class II
Product code
MUD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001842 (2000). 76 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2012: 4 descendants cleared2011: 1 descendant cleared2008: 2 descendants cleared2009: 4 descendants cleared2019: 5 descendants cleared2015: 4 descendants cleared2014: 4 descendants cleared2013: 2 descendants cleared2018: 2 descendants cleared2021: 8 descendants cleared2017: 1 descendant cleared2016: 3 descendants cleared2020: 3 descendants cleared2022: 6 descendants cleared2024: 6 descendants cleared2023: 8 descendants cleared2025: 6 descendants cleared2026: 3 descendants clearedReference device: K040684 · T-Stat Microvascular Tissue Oximeter, Model 303 · Spectros Corporation · 2004Reference device: K963903 · Biospectrometer-NB Oximeter Iiii · Hutchinson Technology, Inc. · 1998K001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 13 descendants3 generations forward: 11 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 11 descendants7 generations forward: 13 descendants8 generations forward: 6 descendants K001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 20000+5
  1. Root · 1 generation backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
  2. This deviceK051274 Invos SystemSomanetics Corp. · 2005
  3. Descendant · cites it directly · 68 of its ownK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  4. Descendant · 2 generations on · 66 of its ownK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  5. Descendant · cites it directly · 58 of its ownK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
  6. 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
  7. Descendant · 2 generations on · 53 of its ownK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2008: 22009: 42010: 42011: 12012: 42013: 22014: 42015: 42016: 32017: 12018: 22019: 52020: 32021: 82022: 62023: 82024: 62025: 62026: 3
2008high 8 (2021) · low 1 (2011)2026

Most influential descendants

Showing 5 of 76 · See all
  • K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008 · cites it directly68descendants
  • K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009 · 2 generations on66descendants
  • K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009 · cites it directly58descendants
  • 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 · 2 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
0 (this device)K051274Invos SystemSomanetics Corp.2005—
+1K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp.2008—
+2K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp.2009—
+1K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.2009—
+1K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.2009—
+2K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models…Cas Medical Systems, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200940
201040
201110
201240
201320
201440
201540
201630
201710
201820
201950
202030
202180
202260
202380
202460
202560
202630
FIG. 1 — Lineage of K051274, 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
*K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100
Summary page 3
…040684) and the Hutchinson InSpectra (K963903). Nonclinical Testing: The INVOS 5100B is identical to the INVOS 5100 Adult/Pediatric Cerebral Oximeter System (K001842) and the SSFB Somatic SomaSensor is identical to the SAFB (KO01842) except that it is supplied with a larger adhesive pad and rev…
Somanetics Corp.2000—
†K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation2004—
†K963903Biospectrometer-NB Oximeter IiiiHutchinson Technology, Inc.1998—

Also cleared against K001842: 9 other devices →

What descends from it? (76)

See all 76

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

NumberDeviceApplicantDecidedDescendants
K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp.200868
K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958
K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957
K102715Regional OximeterNonin Medical, Inc.201053
K113656Careguide OximeterReflectance Medical, Inc.20124
K073407PacificaOr-Nim Medical, Ltd.20081
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?

  • Its one ancestor has no recall.
  • Of its descendants, K080769 (Somanetics Corp., 2008) has gone furthest, with 68 descendants of its own.
  • 9 other devices also cite its predicate K001842.

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 noninvasive INVOS 5100B is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain of an individual. It is also intended for use as an adjunct trend monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in infants, children, or adults at risk for reduced-flow or no-flow ischemic states.

The prospective clinical value of data from the INVOS System 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 K001842

9 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
  • K090807Regional Oximeter System, Model 7600Nonin Medical, Inc. · 20091 recall
  • K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
  • K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008

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
  • K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  • K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  • 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/K051274 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051274: Invos System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051274

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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