Dexcom G6 Continuous Glucose Monitoring (CGM) System
FDA 510(k) clearance K223931 · decided 2023-01-11
Clearance details
- K-number
- K223931
- Device name
- Dexcom G6 Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-30
- Decision date
- 2023-01-11
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- QBJ
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 recall (Z-0318-2026) | Dexcom, Inc. | 2025-10-30 |
| Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT274 recall (Z-1943-2025) | Dexcom, Inc. | 2025-06-16 |
| Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 recall (Z-1202-2025) | Dexcom, Inc. | 2025-02-20 |
| Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 recall (Z-1203-2025) | Dexcom, Inc. | 2025-02-20 |
| Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 recall (Z-1204-2025) | Dexcom, Inc. | 2025-02-20 |
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 |