510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210022Unknown

Pmd-200

Medasense Biometrics Ltd., Ramat Gan, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN210022 is the FDA 510(k) clearance record for PMD-200, a class II device, cleared for Medasense Biometrics , Ltd. on under FDA product code QVE (Adjunctive Pain Measurement Device For Anesthesiology). FDA's definition for product code QVE 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...". FDA records list one 510(k) clearance for Medasense Biometrics , Ltd. As of , FDA records show no recalls naming DEN210022.

Clearance record

Decision date
Received
(623 days to decision)
Product code
QVE Adjunctive Pain Measurement Device For Anesthesiology
Regulation
21 CFR 868.2200
Device class
Class II
Review panel
Anesthesiology
Applicant
Medasense Biometrics , Ltd. 4 Hachilazon St., Ramat Gan, IL
Third party review
No

Clearances, product code QVE

Trailing 12 months

FDA records hold no clearances under product code QVE in the trailing twelve months.

FDA records show no clearances under product code QVE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260