FDA product code QVE: Adjunctive Pain Measurement Device For Anesthesiology

QVE is the FDA product code for adjunctive pain measurement device for anesthesiology. It is a Class II device, regulated under 21 CFR 868.2200 and reviewed by the Anesthesiology panel. Devices under QVE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QVE devices

openFDA lists no recalls for product code QVE.

Frequently asked questions

What is FDA product code QVE?

QVE is the FDA product code for adjunctive pain measurement device for anesthesiology. It is a Class II device, regulated under 21 CFR 868.2200 and reviewed by the Anesthesiology panel.

What device class is QVE?

Class II, regulation 21 CFR 868.2200. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QVE
• Run a recall and safety report across every QVE manufacturer
• Watch product code QVE for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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