Cleared Special

K232722 - endo.digital Platform (FDA 510(k) Clearance)

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

K232722 · DreaMed Diabetes, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
28d
Days
Class 2
Risk

K232722 is an FDA 510(k) clearance for the endo.digital 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 October 3, 2023 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DreaMed Diabetes, Ltd. devices

Submission Details

510(k) Number K232722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2023
Decision Date October 03, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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.