FDA product code QCC: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
QCC is the FDA product code for insulin pump therapy adjustment calculator for healthcare professionals. It is a Class II device, regulated under 21 CFR 862.1358 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under QCC, 1 in the last five years. The average 510(k) review took 96 days (median 72). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Device class | Class II |
| Regulation | 21 CFR 862.1358 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QCC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 57 |
| 2020 | 1 | 86 |
| 2021 | 1 | 215 |
| 2023 | 1 | 28 |
Compare with all 510(k) review times · Search every QCC clearance
Top QCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DreaMed Diabetes, Ltd. | 4 | 2023-10-03 |
Most recent QCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232722 | DreaMed Diabetes, Ltd. | endo.digital Platform | 2023-10-03 | 28 |
| K210561 | DreaMed Diabetes, Ltd. | Advisor Pro Platform | 2021-09-28 | 215 |
| K201476 | DreaMed Diabetes, Ltd. | DreaMed Advisor Pro | 2020-08-28 | 86 |
| K191370 | DreaMed Diabetes, Ltd. | DreaMed Advisor Pro | 2019-07-18 | 57 |
Recalls for QCC devices
openFDA lists no recalls for product code QCC.
Frequently asked questions
What is FDA product code QCC?
QCC is the FDA product code for insulin pump therapy adjustment calculator for healthcare professionals. It is a Class II device, regulated under 21 CFR 862.1358 and reviewed by the Clinical Chemistry panel.
What device class is QCC?
Class II, regulation 21 CFR 862.1358. Typical premarket route: 510(k).
How long does a 510(k) take for product code QCC?
Across 4 cleared submissions the average was 96 days from receipt to decision (median 72).
Which companies have the most QCC clearances?
DreaMed Diabetes, Ltd. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code QCC
- Run a recall and safety report across every QCC manufacturer
- Watch product code QCC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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