De Novo · Granted
GrantedPMD-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medasense Biometrics, Ltd. · QVE Adjunctive Pain Measurement Device For Anesthesiology
Granted on Feb 17, 2023 as a new device type through De Novo after a 623-day review.
- Decided
- Feb 17, 2023
- Review
- 623 days
- Class
- Class II
- Product code
- QVE
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QVE? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All QVE devicesQVE Adjunctive Pain Measurement Device For Anesthesiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVE
Too few QVE 510(k)s in any year since 2007 to give a median.
Recalls per year · QVE
No recall names QVE since 2007.
Adverse event reports per year · QVE
No MAUDE report names QVE since 2007.
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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PMD-200 with the Nociception Level (NOL) Index is indicated for use in a clinical setting that requires assessment of changes in nociception levels in adult patients under general anesthesia receiving opioid or opioid-sparing analgesia as part of their care.
The PMD-200 should be used as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the NOL index in conjunction with other available clinical and vital signs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210022 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210022: PMD-200.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210022
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026