Dexcom, Inc. · Class II · Cleared Dec 17, 2025
| K-number | K253710 |
| Device name | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System |
| Applicant | Dexcom, Inc. |
| Product code | QBJ |
| Device class | Class II |
| Decision date | Dec 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.1355 |
The Dexcom G7 Continuous Glucose Monitoring System and Dexcom G7 15 Day System are real-time CGM devices that continuously measure glucose in interstitial fluid and wirelessly transmit readings to a display device (mobile app or receiver) every 5 minutes. Both systems are indicated for diabetes management in persons 2 years and older (G7) or 18 years and older (G7 15 Day), can replace fingerstick testing, and can communicate with automated insulin dosing systems. The G7 sensor lasts up to 10 days plus a 12-hour grace period; the G7 15 Day sensor lasts up to 15 days plus a 12-hour grace period.
The subject devices have the same fundamental technological characteristics as their predicate devices (K240902 for G7 and K243214 for G7 15 Day). The primary design difference is the introduction of an alternate transmitter on the wearable. Both systems use a wire-type sensing mechanism to measure interstitial glucose and radio transmission for wireless communication; this represents no change in intended use or principle of operation.
EMC testing per IEC 60601-1-2, RTCA DO-160G, and IEC 60601-4-2; wireless coexistence per IEEE ANSI USEMCSC C63.27 and AAMI TIR69; electrical safety per IEC 60601-1 and collateral standards; software verification and validation per IEC 62304 and FDA guidance; cybersecurity per FDA Guidance (September 27, 2023); hardware verification including communication range, reliability, and battery life testing.
The subject devices are substantially equivalent to their predicates because they have identical indications for use, the same fundamental technological characteristics and principle of operation, and the only design difference (an alternate transmitter) does not constitute a new intended use. Comprehensive nonclinical testing demonstrates the devices meet pre-defined acceptance criteria and are as safe and effective as the predicate devices, raising no different questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov