FDA product code QDL: Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
QDL is the FDA product code for integrated continuous glucose monitoring system for professional retrospective use. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under QDL. The average 510(k) review took 59 days (median 59).
Definition
An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitoring System For Professional Retrospective Use |
| Device class | Class II |
| Regulation | 21 CFR 862.1355 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QDL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 59 |
Compare with all 510(k) review times · Search every QDL clearance
Top QDL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dexcom, Inc. | 1 | 2018-11-02 |
Most recent QDL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182405 | Dexcom, Inc. | Dexcom Pro Q Continuous Glucose Monitoring System | 2018-11-02 | 59 |
Recalls for QDL devices
openFDA lists no recalls for product code QDL.
Frequently asked questions
What is FDA product code QDL?
QDL is the FDA product code for integrated continuous glucose monitoring system for professional retrospective use. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel.
What device class is QDL?
Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDL?
Across 1 cleared submissions the average was 59 days from receipt to decision (median 59).
Which companies have the most QDL clearances?
Dexcom, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDL
- Run a recall and safety report across every QDL manufacturer
- Watch product code QDL 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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