Not Cleared Direct

DEN170043 - DreaMed Advisor Pro (FDA 510(k) Clearance)

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

DEN170043 · DreaMed Diabetes, Ltd. · Chemistry device
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Jun 2018
Decision
299d
Days
Class 2
Risk

DEN170043 is an FDA 510(k) submission (not cleared) for the DreaMed Advisor Pro. Classified as Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals (product code QCC), Class II - Special Controls.

Submitted by DreaMed Diabetes, Ltd. (Petah Tikva, Pob 3271, IL). The FDA issued a Not Cleared (DENG) decision on June 12, 2018 after a review of 299 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1358 - the FDA in vitro diagnostics and chemistry 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 299 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 DreaMed Diabetes, Ltd. devices

Submission Details

510(k) Number DEN170043 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 17, 2017
Decision Date June 12, 2018
Days to Decision 299 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 88d · This submission: 299d
Pathway characteristics

Device Classification

Product Code QCC Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1358
Definition An Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Is Intended To Recommend Insulin Pump Therapy Parameter Adjustments (e.g., Basal Rate, Insulin To Carbohydrate Ratios, Insulin Sensitivity Factors) Based On Data From External Devices, Including Continuous Glucose Monitors.
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 Chemistry devices follow this clearance model.