QCC
5 FDA 510(k) clearances · Product code
86 daysmedian time to decision
299 days90th percentile
5clearances measured
FDA profile
- Official device name
- Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1358
- Medical specialty
- Clinical Chemistry
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| endo.digital Platform (K232722) | DreaMed Diabetes, Ltd. | 2023-10-03 |
| Advisor Pro Platform (K210561) | DreaMed Diabetes, Ltd. | 2021-09-28 |
| DreaMed Advisor Pro (K201476) | DreaMed Diabetes, Ltd. | 2020-08-28 |
| DreaMed Advisor Pro (K191370) | DreaMed Diabetes, Ltd. | 2019-07-18 |
| DreaMed Advisor Pro (DEN170043) | DreaMed Diabetes, Ltd. | 2018-06-12 |
Track QCC automatically
Every clearance here is in the API, with alerts when new ones post.