Cleared Traditional

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

Class II Chemistry device cleared through predicate-based substantial equivalence.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01308164 Completed Interventional

MD Logic Pump Advisor -Pediatric Study

Evaluation of Automated-Insulin Pump Setting Using the MD-Logic Pump Advisor -Minors Sub Study

25
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Type 1 Diabetes
Study design Parallel
Eligibility All sexes · 10 Years+
Principal investigator Moshe Phillip, Prof
Sponsor Rabin Medical Center
Started 2011-03-01 → Primary completion 2017-01-01
Primary outcome
Time spent in the normal range
Secondary outcome
Number of iterations required to achieve the maximal time spent in the normal range
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov