510(k) Report

510(k) · Cleared

Cleared

Adult/Pediatric Cerebral Oximeter, Model Invos 5100

K001842510(k) TraditionalCleared Sep 15, 200088-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. · DQA Oximeter

Cleared on Sep 15, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 85 later devices descend from it.

Decided
Sep 15, 2000
Review
88 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

85 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2009: 5 descendants cleared2005: 2 descendants cleared2006: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2008: 4 descendants cleared2012: 5 descendants cleared2019: 6 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 cleared200020052010201520202025
  1. This deviceK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
  2. Descendant · cites it directly · 76 of its ownK051274 Invos SystemSomanetics Corp. · 2005
  3. Descendant · 2 generations on · 68 of its ownK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  4. Descendant · cites it directly · 67 of its ownK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
  5. Descendant · 3 generations on · 66 of its ownK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  6. Descendant · cites it directly · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 12008: 42009: 52010: 42011: 12012: 52013: 22014: 42015: 42016: 32017: 12018: 22019: 62020: 32021: 82022: 62023: 82024: 62025: 62026: 3
2004high 8 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 85 · See all
  • K051274Invos SystemSomanetics Corp. · 2005 · cites it directly76descendants
  • K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008 · 2 generations on68descendants
  • K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004 · cites it directly67descendants
  • K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009 · 3 generations on66descendants
  • K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005 · cites it directly63descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
+1K051274Invos SystemSomanetics Corp.2005—
+2K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp.2008—
+1K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation2004—
+3K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp.2009—
+1K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200610
200840
200950
201040
201110
201250
201320
201440
201540
201630
201710
201820
201960
202030
202180
202260
202380
202460
202560
202630
FIG. 1 — Lineage of K001842, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (85)

See all 85

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

NumberDeviceApplicantDecidedDescendants
K051274Invos SystemSomanetics Corp.200576
K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467
K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563
K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859
K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659
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
K090807Regional Oximeter System, Model 7600Nonin Medical, Inc.200954
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?

  • Of its descendants, K051274 (Somanetics Corp., 2005) has gone furthest, with 76 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

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
  • K051274Invos SystemSomanetics Corp. · 2005

Recent decisions in DQA

The DQA category page

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  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
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https://510kreport.com/device/K001842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001842

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026