FDA product code QDK: Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
QDK is the FDA product code for integrated continuous glucose monitoring system for non-intensive diabetes management. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under QDK. The average 510(k) review took 113 days (median 59).
Definition
An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management |
| 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 QDK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 88 |
| 2019 | 1 | 25 |
| 2020 | 1 | 30 |
| 2021 | 1 | 308 |
Compare with all 510(k) review times · Search every QDK clearance
Top QDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dexcom, Inc. | 4 | 2021-08-17 |
Most recent QDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203089 | Dexcom, Inc. | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | 2021-08-17 | 308 |
| K193642 | Dexcom, Inc. | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | 2020-01-29 | 30 |
| K192787 | Dexcom, Inc. | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | 2019-10-25 | 25 |
| K182041 | Dexcom, Inc. | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | 2018-10-26 | 88 |
Recalls for QDK devices
openFDA lists no recalls for product code QDK.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0422 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring with exercise, per session
- G0423 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring; without exercise, per session
Frequently asked questions
What is FDA product code QDK?
QDK is the FDA product code for integrated continuous glucose monitoring system for non-intensive diabetes management. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel.
What device class is QDK?
Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDK?
Across 4 cleared submissions the average was 113 days from receipt to decision (median 59).
Which companies have the most QDK clearances?
Dexcom, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code QDK
- Run a recall and safety report across every QDK manufacturer
- Watch product code QDK 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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