510(k) Report

510(k) · Cleared

Cleared

Somanetics Invos 3100A Cerebral Oximeter (Invos)

K960614510(k) TraditionalCleared Jun 5, 1996113-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 Jun 5, 1996 as substantially equivalent to K863784 (Nellcor, Inc., 1986) and 1 other predicate after a 113-day review. Its family tree reaches back 1 generation to 1986. 67 later devices descend from it.

Decided
Jun 5, 1996
Review
113 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K863784 (1986). 2 ancestors in all. 67 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1988: 1 other ancestor2010: 4 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared1997: 1 descendant cleared2011: 1 descendant cleared2008: 2 descendants cleared2009: 2 descendants cleared2012: 2 descendants cleared2019: 4 descendants cleared2015: 3 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2016: 2 descendants cleared2020: 3 descendants cleared2022: 6 descendants cleared2018: 1 descendant cleared2021: 7 descendants cleared2017: 1 descendant cleared2024: 6 descendants cleared2023: 8 descendants cleared2025: 6 descendants cleared2026: 3 descendants clearedK863784 · Nellcor N-200 (Pulse Oximeter) · Nellcor, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 3 descendants3 generations forward: 8 descendants4 generations forward: 5 descendants5 generations forward: 7 descendants6 generations forward: 6 descendants7 generations forward: 11 descendants8 generations forward: 13 descendants9 generations forward: 6 descendants K863784 · Nellcor N-200 (Pulse Oximeter) · Nellcor, Inc. · 19860+5
  1. Root · 1 generation backK863784 Nellcor N-200 (Pulse Oximeter)Nellcor, Inc. · 1986
  2. This deviceK960614 Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp. · 1996
  3. Descendant · cites it directly · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
  4. Descendant · cites it directly · 59 of its ownK073036 Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
  5. Descendant · cites it directly · 59 of its ownK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
  6. 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
  7. 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

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

1997: 12005: 12006: 12008: 22009: 22010: 42011: 12012: 22013: 12014: 22015: 32016: 22017: 12018: 12019: 42020: 32021: 72022: 62023: 82024: 62025: 62026: 3
1997high 8 (2023) · low 0 (1998)2026

Most influential descendants

Showing 5 of 67 · See all
  • K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005 · cites it directly63descendants
  • K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008 · cites it directly59descendants
  • K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006 · cites it directly59descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863784Nellcor N-200 (Pulse Oximeter)Nellcor, Inc.1986—
0 (this device)K960614Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp.1996—
+1K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.2005—
+1K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.2008—
+1K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.2006—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200510
200610
200820
200920
201040
201110
201220
201310
201420
201530
201620
201710
201810
201940
202030
202170
202260
202380
202460
202560
202630
FIG. 1 — Lineage of K960614, 1986–2026Source: 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 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? (2)

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
*K863784Nellcor N-200 (Pulse Oximeter)
Summary page 1
…-TC Travel Case 3100A-M Additional User Manual 4. Classification Name: Oximeters 5. Common Name: Cerebral Oximeter 6. Predicate Devices: Nellcor N-200 Pulse Oximeter (K863784) Baxter SAT-II Intravascular Oximetry System (K884329) 7. Indications for Use: The noninvasive INVOS 3100A Cerebral Oximeter sho…
Nellcor, Inc.1986—
*K884329Sat-2 Oximeter/Cardiac Output Computer
Summary page 1
…ssification Name: Oximeters 5. Common Name: Cerebral Oximeter 6. Predicate Devices: Nellcor N-200 Pulse Oximeter (K863784) Baxter SAT-II Intravascular Oximetry System (K884329) 7. Indications for Use: The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends…
Baxter Healthcare Corp1988—

Also cleared against K863784: 13 other devices →

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
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
K971628Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp.19972
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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K051257 (Cas Medical Systems, Inc., 2005) has gone furthest, with 63 descendants of its own.
  • 13 other devices also cite its predicate K863784.

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—

What is it indicated for?

The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K863784

13 other devices cite the same predicate.

  • K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC · 2010
  • K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006
  • K051212Modification to LNCS Oximetry SensorsMasimo Corporation · 20055 recalls
  • K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and Adhesive SPO2 SensorsMediaid, Inc. · 2004
  • K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc. · 2004
  • K041204NC SP02 Adapter CableMasimo Corp. · 2004

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

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K960614 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960614

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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