510(k) · Cleared
ClearedVO200 – NeurOs Cerebral Oximetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mespere Lifesciences, Inc. · QEM Cerebral Oximeter
Cleared on Dec 26, 2018 as substantially equivalent to K082327 (Somanetics Corp., 2009) after a 128-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 26, 2018
- Review
- 128 days
- Class
- Class II
- Product code
- QEM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001842 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
- 3 generations backK051274 Invos SystemSomanetics Corp. · 2005
- 2 generations backK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
- 1 generation backK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
- This deviceK182242 VO200 – NeurOs Cerebral Oximetry SystemMespere Lifesciences, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100 | Somanetics Corp. | 2000 | — |
| −3 | K051274 | Invos System | Somanetics Corp. | 2005 | — |
| −2 | K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100C | Somanetics Corp. | 2008 | — |
| −1 | K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100C | Somanetics Corp. | 2009 | — |
| 0 (this device) | K182242 | VO200 – NeurOs Cerebral Oximetry System | Mespere Lifesciences, Inc. | 2018 | — |
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 QEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100CSummary page 4…imetry Classification Oximeter, Tissue Saturation (21CFR 870.2700) name: Classification: Class II Medical Device Product Code: QEM Predicate Device: K082327 INVOS 5100C Cerebral/Somatic Oximeter System Product Code: QEM Regula… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 9 other devices also cite its predicate K082327.
How does its category compare?
All QEM devicesQEM Cerebral Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QEM
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QEM
Too few QEM 510(k)s in any year since 2007 to give a median.
Recalls per year · QEM
No recall names QEM since 2007.
Adverse event reports per year · QEM
1in 2019
MAUDE reports naming product code QEM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VO200 – NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182242: VO200 – NeurOs Cerebral Oximetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182242
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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