Not Cleared Direct

DEN210022 - PMD-200 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210022 · Medasense Biometrics , Ltd. · Anesthesiology device
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Feb 2023
Decision
623d
Days
Class 2
Risk

DEN210022 is an FDA 510(k) submission (not cleared) for the PMD-200. Classified as Adjunctive Pain Measurement Device For Anesthesiology (product code QVE), Class II - Special Controls.

Submitted by Medasense Biometrics , Ltd. (Ramat Gan, IL). The FDA issued a Not Cleared (DENG) decision on February 17, 2023 after a review of 623 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2200 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 623 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN210022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 04, 2021
Decision Date February 17, 2023
Days to Decision 623 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
484d slower than avg
Panel avg: 139d · This submission: 623d
Pathway characteristics

Device Classification

Product Code QVE Adjunctive Pain Measurement Device For Anesthesiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2200
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.