# DEN210022: PMD-200

- Pathway: De Novo (Direct)
- Applicant: Medasense Biometrics, Ltd.
- Decided: Feb 17, 2023 after 623 days
- Product code: QVE (Adjunctive Pain Measurement Device For Anesthesiology)
- Device class: 2
- Regulation: 21 CFR 868.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN210022
Methodology: https://510kreport.com/methodology