Cleared Traditional

K191370 - DreaMed Advisor Pro (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191370 · DreaMed Diabetes, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
57d
Days
Class 2
Risk

K191370 is an FDA 510(k) clearance 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, IL). The FDA issued a Cleared decision on July 18, 2019 after a review of 57 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DreaMed Diabetes, Ltd. devices

Submission Details

510(k) Number K191370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date July 18, 2019
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.