DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S033 · decided 2015-08-19
Approval details
- PMA number
- P120005
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2015-02-25
- Decision date
- 2015-08-19
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR CHANGES TO THE DEXCOM TRANSMITTER AND RECEIVER AND THE ADDITION OF THE DEXCOM G5 MOBILE APP, TO ENABLE THE TRANSMISSION OF CGM DATA TO THE RECEIVER AND/OR COMPATIBLE APPLE MOBILE DEVICES, AND TO ALLOW ENTRY OF SYSTEM CALIBRATION INFORMATION DIRECTLY FROM COMPATIBLE APPLE MOBILE DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Stelo Glucose Biosensor System (K260935) | Dexcom, Inc. | 2026-06-12 |
| Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (K261402) | Dexcom, Inc. | 2026-06-08 |
| Stelo Glucose Biosensor System (K261359) | Dexcom, Inc. | 2026-05-21 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253737) | Dexcom, Inc. | 2026-02-03 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253710) | Dexcom, Inc. | 2025-12-17 |
| Dexcom Smart Basal (K252818) | Dexcom, Inc. | 2025-11-18 |
| Dexcom G7 15 Day Continuous Glucose Monitoring System (K243214) | Dexcom, Inc. | 2025-04-09 |
| Dexcom G7 Continuous Glucose Monitoring System (K240902) | Dexcom, Inc. | 2024-04-23 |