QCC — Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Class II
FDA product code QCC covers "Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals", a Class II medical device regulated under 21 CFR 862.1358. Submissions are reviewed by the Clinical Chemistry panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QCC
- Device Class
- Class II
- Regulation Number
- 862.1358
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232722 | dreamed diabetes | endo.digital Platform | October 3, 2023 |
| K210561 | dreamed diabetes | Advisor Pro Platform | September 28, 2021 |
| K201476 | dreamed diabetes | DreaMed Advisor Pro | August 28, 2020 |
| K191370 | dreamed diabetes | DreaMed Advisor Pro | July 18, 2019 |
| DEN170043 | dreamed diabetes | DreaMed Advisor Pro | June 12, 2018 |