QVEClass II

Adjunctive Pain Measurement Device For Anesthesiology

21 CFR 868.2200 / Anesthesiology

QVE is the FDA product code for Adjunctive Pain Measurement Device For Anesthesiology, a class II device type, regulated under 21 CFR 868.2200. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2023-02-17, and no recalls.

Classification record

Product code: QVE
Device name: Adjunctive Pain Measurement Device For Anesthesiology
FDA 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.
Regulation: 21 CFR 868.2200
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QVE

By decision year

1 clearance under product code QVE with a decision year between 2023 and 2023, 2023 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QVE by decision year
Year	Clearances
2023	1

Applicants with the most clearances

Product code QVE

Applicants holding the most 510(k) clearances under product code QVE
Applicant	Clearances
Medasense Biometrics Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QVE

DEN210022Class IIPmd-200Medasense Biometrics , Ltd. / cleared 2023-02-17

Recent recalls

Product code QVE

FDA records show no recalls under product code QVE.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)