DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P120005/S049 · decided 2016-09-16
Approval details
- PMA number
- P120005
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2016-06-21
- Decision date
- 2016-09-16
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for updates to the G5 Mobile iOS App Software and G5 Mobile Transmitter Firmware for Dexcoms G5 Mobile Continuous Glucose Monitoring System. The App is being modified to: backfill data from the CGM if there are data gaps within the last 3 hours; include mute override settings, which allow users to hear alerts critical to safe and effective use of the device even when their smart device is muted or turned to a very low volume; and to correct software anomalies. The Transmitter Firmware
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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 |