510(k) K213919 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G7 Continuous Glucose Monitoring System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 7, 2022 |
| Received | Dec 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM Android App
Model/Catalog Number: SW12299
Software Version: version 2.8.0 and earlier
Product Description: Dexcom Open, Classified |
QBJ | None listed |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM iOS App
Model/Catalog Number: SW12300
Software Version: version 2.8.0 and earlier
Product Description: Dexcom G7 Open, Classified |
QBJ | None listed |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM watchOS App
Model/Catalog Number: SW13355
Software Version: versions 2.8.0 and earlier
Product Description: Dexco Open, Classified |
QBJ | None listed |
| Jun 16, 2025 | Dexcom, Inc. Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT Open, Classified |
QBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.