Dexcom G5 Mobile Continuous Glucose Monitoring System
FDA premarket approval P120005/S086 · decided 2020-01-08
Approval details
- PMA number
- P120005
- Supplement
- S086
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Generic name
- Sensor, glucose, invasive
- Applicant
- Dexcom, Inc.
- Date received
- 2019-12-09
- Decision date
- 2020-01-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Addition of a Clean Environment Room and associated support rooms to the existing manufacturing space for manufacturing sensors of the G4 PLATINUM/G5 Mobile Continuous Glucose Monitoring (CGM) System.
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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 |