Cleared Traditional

K210561 - Advisor Pro Platform (FDA 510(k) Clearance)

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

K210561 · DreaMed Diabetes, Ltd. · Chemistry device
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Sep 2021
Decision
215d
Days
Class 2
Risk

K210561 is an FDA 510(k) clearance for the Advisor Pro Platform. 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 September 28, 2021 after a review of 215 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all DreaMed Diabetes, Ltd. devices

Submission Details

510(k) Number K210561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2021
Decision Date September 28, 2021
Days to Decision 215 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
127d slower than avg
Panel avg: 88d · This submission: 215d
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.