DeviceClearance

Product code QVE— Anesthesiology

PMD-200

Classification name
Adjunctive Pain Measurement Device For Anesthesiology
Device class
Class 2
Regulation
21 CFR 868.2200
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QVE under 21 CFR 868.2200, via openFDA

Market context for product code QVE

FDA has cleared 1 device under product code QVE, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QVE

Recent clearances under product code QVE

Data sourced from openFDA. This site is unofficial and independent of the FDA.