510(k) · Cleared
ClearedSomanetics Invos 3100A Cerebral Oximeter (Invos)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somanetics Corp. · DQA Oximeter
Cleared on Oct 10, 1997 as substantially equivalent to K960614 (Somanetics Corp., 1996) after a 161-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Oct 10, 1997
- Review
- 161 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863784 (1986). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK863784 Nellcor N-200 (Pulse Oximeter)Nellcor, Inc. · 1986
- 1 generation backK960614 Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp. · 1996
- This deviceK971628 Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp. · 1997
- Descendant · cites it directly · 0 of its ownK111007 Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest…Midwest Reprocessing Center, LLC · 2011
- Descendant · cites it directly · 0 of its ownK100523 Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic…Hygia Health Services, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See all- K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center…Midwest Reprocessing Center, LLC · 2011 · cites it directly0descendants
- K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…Hygia Health Services, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863784 | Nellcor N-200 (Pulse Oximeter) | Nellcor, Inc. | 1986 | — |
| −1 | K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos) | Somanetics Corp. | 1996 | — |
| 0 (this device) | K971628 | Somanetics Invos 3100A Cerebral Oximeter (Invos) | Somanetics Corp. | 1997 | — |
| +1 | K111007 | Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing… | Midwest Reprocessing Center, LLC | 2011 | — |
| +1 | K100523 | Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry… | Hygia Health Services, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960614 | Somanetics Invos 3100A Cerebral Oximeter (Invos)Summary page 1…odem Cable 4. Classification Name: Oximeters 5. Common Name: Cerebral Oximeter 6. Predicate Device: Somanetics INVOS® 3100A Cerebral Oximeter with 3100- SD SomaSensor® (K960614) 7. Indications for Use: The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111007 (Midwest Reprocessing Center, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K960614.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The noninvasive INVOS 3100A Cerebral Oximeter is intended for use 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.
https://510kreport.com/device/K971628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971628: 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/K971628
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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