QDK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Medical specialty
- Clinical Chemistry
- FDA 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.
- Adverse events (MAUDE)
- 2020: 18 · 2021: 111 · 2022: 81 · 2023: 78 · 2024: 238 · 2025: 66
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K203089) | Dexcom, Inc. | 2021-08-17 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K193642) | Dexcom, Inc. | 2020-01-29 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System (K192787) | Dexcom, Inc. | 2019-10-25 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) | Dexcom, Inc. | 2018-10-26 |
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Every clearance here is in the API, with alerts when new ones post.