Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
FDA 510(k) clearance K203089 · decided 2021-08-17
Clearance details
- K-number
- K203089
- Device name
- Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-13
- Decision date
- 2021-08-17
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- QDK
- Device class
- 2
- Regulation number
- 862.1355
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin (P120005/S091) | Dexcom, Inc. | 2024-01-09 |
| DEXCOM G5 Mobile Continuous Glucose Monitoring System (P120005/S090) | Dexcom, Inc. | 2023-01-12 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S088) | Dexcom, Inc. | 2022-01-20 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S089) | Dexcom, Inc. | 2021-12-21 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S087) | Dexcom, Inc. | 2020-09-03 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S086) | Dexcom, Inc. | 2020-01-08 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S083) | Dexcom, Inc. | 2019-11-01 |
| Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S082) | Dexcom, Inc. | 2019-08-20 |