Dexcom G7 Continuous Glucose Monitoring System— 510(k) K213919
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K213919 for Dexcom G7 Continuous Glucose Monitoring System, Substantially Equivalent on 2022-12-07. Applicant: Dexcom, Inc.. Device class: 2.
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Code QBJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code QBJ
view all- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System
- K233537 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
More clearances from Dexcom, Inc.
view allAdverse events under product code QBJ
product code QBJ- Death
- 180
- Injury
- 31,825
- Malfunction
- 1,792,244
- Other
- 36
- Total
- 1,824,285
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K213919
K-number listed on FDA's recall record- Z-2446-2025 — 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 G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System
- Z-2447-2025 — 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 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
- Z-2448-2025 — 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: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App
- Z-1944-2025 — 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-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213919.
Data sourced from openFDA. This site is unofficial and independent of the FDA.