Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
FDA 510(k) K203089 · Dexcom, Inc.
Submission
- Device name
- Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc.
San Diego, CA, US - Received
- October 13, 2020
- Decision date
- August 17, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDK – Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Specialty
- Clinical Chemistry
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…
Other 510(k)s with product code QDK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemQDK · Special | Dexcom, Inc. | 01/29/2020SE |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemQDK · Special | Dexcom, Inc. | 10/25/2019SE |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemQDK · Traditional | Dexcom, Inc. | 10/26/2018SE |
More from Dexcom, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262472 | Stelo Glucose Biosensor SystemSBH · Special | 08/11/2026SE |
| K260935 | Stelo Glucose Biosensor SystemSBH · Traditional | 06/12/2026SE |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…QBJ · Traditional | 06/08/2026SE |
| K261359 | Stelo Glucose Biosensor SystemSAF · Special | 05/21/2026SE |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…QBJ · Traditional | 02/03/2026SE |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…QBJ · Special | 12/17/2025SE |
| K252818 | Dexcom Smart BasalQRX · Traditional | 11/18/2025SE |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ · Traditional | 04/09/2025SE |
| K240902 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Special | 04/23/2024SE |
| K234070 | Stelo Glucose Biosensor SystemSAF · Traditional | 03/05/2024SE |
Questions and answers
When was Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System cleared by the FDA?
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K203089) received a 510(k) decision of Substantially Equivalent on August 17, 2021, 308 days after the submission was received.
What is the product code of K203089?
The FDA product code is QDK – Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management, a Class II (moderate risk) device regulated under 21 CFR 862.1355.