DreaMed Advisor Pro is an AI-enabled medical device from DreaMed Diabetes Ltd that the U.S. FDA cleared through 510(k) K191370 on July 18, 2019. Its lead review panel is Clinical Chemistry and its primary product code is QCC (Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals).
See also all FDA AI clearances in 2019.
Key facts
| Submission number | K191370 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | DreaMed Diabetes Ltd |
| Lead review panel | Clinical Chemistry |
| Primary product code | QCC — Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Applicant (openFDA) | DreaMed Diabetes, Ltd. |
| Applicant location | Petah Tikva, IL |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.1358 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. DreaMed Advisor Pro went through this pathway (K191370).
openFDA lists it as a Class 2 device under 21 CFR 862.1358. Class II devices are moderate risk and are subject to general and special controls.
Product code QCC covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. DreaMed Diabetes Ltd has 2 AI-enabled devices on the list, and the Clinical Chemistry panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.