Dexcom G6 Continuous Glucose Monitoring (CGM) System— 510(k) K223931
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K223931 for Dexcom G6 Continuous Glucose Monitoring (CGM) System, Substantially Equivalent on 2023-01-11. 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
- Special
- 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 K223931
K-number listed on FDA's recall record- Z-0318-2026 — 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: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System
- Z-1943-2025 — Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
- Z-1202-2025 — Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
- Z-1203-2025 — Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
- Z-1204-2025 — Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223931.
Data sourced from openFDA. This site is unofficial and independent of the FDA.