Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
The Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals is a software device intended to recommend insulin pump therapy parameter adjustments, such as basal rate, insulin-to-carbohydrate ratios, and insulin sensitivity factors, based on data from external devices including continuous glucose monitors. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence. The product code is QCC under regulation 862.1358 in the Clinical Chemistry specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QCC
- Device Class
- FDA class 2
- Regulation Number
- 862.1358
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232722 | endo.digital Platform | Oct 03, 2023 | Substantially Equivalent | DreaMed Diabetes, Ltd. |
| K210561 | Advisor Pro Platform | Sep 28, 2021 | Substantially Equivalent | DreaMed Diabetes, Ltd. |
| K201476 | DreaMed Advisor Pro | Aug 28, 2020 | Substantially Equivalent | DreaMed Diabetes, Ltd. |
| K191370 | DreaMed Advisor Pro | Jul 18, 2019 | Substantially Equivalent | DreaMed Diabetes, Ltd. |
| DEN170043 | DreaMed Advisor Pro | Jun 12, 2018 | Unknown | DreaMed Diabetes, Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.