Not Cleared Direct

DEN200038 - Gili Pro BioSensor (also known as “Gili BioSensor System”) (FDA 510(k) Clearance)

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

DEN200038 · Continuse Biometrics , Ltd. · Cardiovascular device
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Apr 2021
Decision
293d
Days
Class 2
Risk

DEN200038 is an FDA 510(k) submission (not cleared) for the Gili Pro BioSensor (also known as “Gili BioSensor System”). Classified as Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate (product code QOK), Class II - Special Controls.

Submitted by Continuse Biometrics , Ltd. (Tel-Aviv, IL). The FDA issued a Not Cleared (DENG) decision on April 1, 2021 after a review of 293 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2786 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. With 293 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.

View all Continuse Biometrics , Ltd. devices

Submission Details

510(k) Number DEN200038 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 12, 2020
Decision Date April 01, 2021
Days to Decision 293 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 125d · This submission: 293d
Pathway characteristics

Device Classification

Product Code QOK Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2786
Definition The Device Uses An Optical Sensor System And Software Algorithms To Obtain And Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device Is Not Intended To Independently Direct Therapy.
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 Cardiovascular devices follow this clearance model.