DeviceClearance

Product code QCC— Clinical Chemistry

DreaMed Advisor Pro

Classification name
Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
Device class
Class 2
Regulation
21 CFR 862.1358
Advisory panel
Clinical Chemistry
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QCC under 21 CFR 862.1358, via openFDA

Market context for product code QCC

FDA has cleared 5 devices under product code QCC between 2018 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QCC

Recent clearances under product code QCC

Data sourced from openFDA. This site is unofficial and independent of the FDA.