Dexcom G7 Continuous Glucose Monitoring (CGM) System
FDA 510(k) K231081 · Dexcom, Inc.
Submission
- Device name
- Dexcom G7 Continuous Glucose Monitoring (CGM) System
- Applicant
- Dexcom, Inc.
San Diego, CA, US - Received
- April 17, 2023
- Decision date
- May 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBJ – Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Specialty
- Clinical Chemistry
An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with…
Other 510(k)s with product code QBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…QBJ · Traditional | Dexcom, Inc. | 06/08/2026SE |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…QBJ · Traditional | Dexcom, Inc. | 02/03/2026SE |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…QBJ · Special | Dexcom, Inc. | 12/17/2025SE |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ · Traditional | Dexcom, Inc. | 04/09/2025SE |
| K240902 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Special | Dexcom, Inc. | 04/23/2024SE |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | Abbott Diabetes Care, Inc. | 04/23/2024SE |
| K234133 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Traditional | Dexcom, Inc. | 02/26/2024SE |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose…QBJ · Traditional | Abbott Diabetes Care, Inc. | 04/13/2023SE |
| K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose…QBJ · Traditional | Abbott Diabetes Care, Inc. | 03/03/2023SE |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ · Special | Dexcom, Inc. | 01/11/2023SE |
More from Dexcom, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262472 | Stelo Glucose Biosensor SystemSBH · Special | 08/11/2026SE |
| K260935 | Stelo Glucose Biosensor SystemSBH · Traditional | 06/12/2026SE |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…QBJ · Traditional | 06/08/2026SE |
| K261359 | Stelo Glucose Biosensor SystemSAF · Special | 05/21/2026SE |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…QBJ · Traditional | 02/03/2026SE |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…QBJ · Special | 12/17/2025SE |
| K252818 | Dexcom Smart BasalQRX · Traditional | 11/18/2025SE |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ · Traditional | 04/09/2025SE |
| K240902 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Special | 04/23/2024SE |
| K234070 | Stelo Glucose Biosensor SystemSAF · Traditional | 03/05/2024SE |
Questions and answers
When was Dexcom G7 Continuous Glucose Monitoring (CGM) System cleared by the FDA?
Dexcom G7 Continuous Glucose Monitoring (CGM) System (K231081) received a 510(k) decision of Substantially Equivalent on May 15, 2023, 28 days after the submission was received.
What is the product code of K231081?
The FDA product code is QBJ – Integrated Continuous Glucose Monitoring System, Factory Calibrated, a Class II (moderate risk) device regulated under 21 CFR 862.1355.