510(k) K243214 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G7 15 Day Continuous Glucose Monitoring System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 9, 2025 |
| Received | Oct 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2026 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM iOS App
Model/Catalog Number: SW12300
Software Version: Versions 2.9.0 through 2.11.2
Product Description: Dexcom Open, Classified |
QBJ | None listed |
| May 11, 2026 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM watchOS App
Model/Catalog Number: SW13355
Software Version: Versions 2.9.0 through 2.11.2
Product Description: De Open, Classified |
QBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.