510(k) K223931 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G6 Continuous Glucose Monitoring (CGM) System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 11, 2023 |
| Received | Dec 30, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2025 | Dexcom, Inc. Brand Name: Dexcom G6 Continuous Glucose Monitoring System
Product Name: Dexcom G6 and G6 Pro Android US CGM App
Model/Catalog Number: SW11678
Software Version: version 1.15.0
Product Description: Dex Open, Classified |
QBJ | None listed |
| Jun 16, 2025 | Dexcom, Inc. Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) Open, Classified |
QBJ | None listed |
| Feb 20, 2025 | Dexcom, Inc. Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 Open, Classified |
QBJ | None listed |
| Feb 20, 2025 | Dexcom, Inc. Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 Open, Classified |
QBJ | None listed |
| Feb 20, 2025 | Dexcom, Inc. Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 Open, Classified |
QBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.