QVE · Class II · 21 CFR 868.2200

FDA Product Code QVE: Adjunctive Pain Measurement Device For Anesthesiology

An Adjunctive Pain Measurement Device For Anesthesiology Is A Prescription Device That Includes Software Algorithms To Analyze Physiological Sensor Data And Measure Response To Painful Stimuli In Patients Under General Anesthesia. The Device May Be Software-only Or It May Include Hardware Such As Physiological Sensors. This Device Type Is Intended For Adjunctive Use To Tailor Analgesic Administration To A Patient’s Actual Response To Painful Stimuli And Is Not Intended To Independently Direct Decision-making.

Leading manufacturers include Medasense Biometrics , Ltd..

1
Total
0
Cleared
623d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Adjunctive Pain Measurement Device For Anesthesiology Devices (Product Code QVE)

1 devices
1–1 of 1
Not Cleared Feb 17, 2023
PMD-200
DEN210022
Medasense Biometrics , Ltd.
Anesthesiology · 623d

About Product Code QVE - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QVE since 2023, with 0 receiving FDA clearance (average review time: 623 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QVE devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →