Clinical Chemistry · 510(k) · 2019
DreaMed Advisor Pro
DreaMed Diabetes Ltd. Cleared by FDA on 18 July 2019 under submission K191370, product code QCC (insulin pump therapy adjustment calculator for healthcare professionals). What FDA's record says, in FDA's words.
Device record · K191370
- Device. DreaMed Advisor ProDEVICE
- Company. DreaMed Diabetes Ltd (IL)COMPANY
- Decision. 18 July 2019, 510(k), substantially equivalent (traditional review); received 22 May 2019DECISION
- Panel. Clinical ChemistryPANEL
- Product code. QCC, Insulin Pump Therapy Adjustment Calculator For Healthcare ProfessionalsCODE
- Regulation. 21 CFR 862.1358, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who: •use insulin pumps as their insulin delivery therapy; • monitor their glucose levels using CGM and/or self-management blood glucose meter; • are above the age of 6 and under 65 years old; and • use rapid acting U-100 insulin analogs in their pump. DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing continuous glucose monitoring (CGM), self-monitoring blood glucose (SMBG) and pump data to generate recommendations for optimizing a patient’s insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF); without considering the full
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QCC. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QCC, in Clinical Chemistry, from DreaMed Diabetes Ltd, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.