Dexcom G7 GSS
The Dexcom G7 Glucose Sensing Subsystem includes the sensor applicator and an on-body wearable with a sensor, transmitter and adhesive patch. Used within the G7 continuous glucose…
The Dexcom G7 Glucose Sensing Subsystem includes the sensor applicator and an on-body wearable with a sensor, transmitter and adhesive patch. Used within the G7 continuous glucose monitoring system, it measures glucose for diabetes management in people aged two years and older.
The applicator inserts a flexible sensor wire into subcutaneous tissue and attaches the wearable to the skin. The wire produces an electrical current related to glucose; the transmitter converts the measurements into estimated glucose values and rate-of-change information.
Wear and Transmission
The sensor is designed for up to ten days of wear followed by a twelve-hour grace period. Its integrated transmitter sends glucose information every five minutes to the compatible G7 mobile application or receiver. Interpretation uses trends and several sequential readings over time.
1manufacturer
5catalogue numbers in this listing
15510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Dexcom, Inc., United States |
|---|---|
| FDA product code | QBJ |
| Device type | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1355 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K213919 |
| Record published | 2023-03-30 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STP-AT-011 | In distribution | |
| 9500-151 | In distribution | |
| STP-AT-013 | In distribution | |
| STP-AT-012 | In distribution | |
| 9500-155 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | 6 |
| Dexcom G6 Receiver | Dexcom, Inc. | 5 |
| FreeStyle Libre 3 Plus | Abbott Diabetes Care Limited | 5 |
| Dexcom G7 Receiver | Dexcom, Inc. | 4 |
| FreeStyle Libre 2 Plus | Abbott Diabetes Care Limited | 4 |
| Dexcom G7 GSS (161) | Dexcom, Inc. | 4 |
| Dexcom G7 GSS (160) | Dexcom, Inc. | 4 |
| FreeStyle Libre 3 | Abbott Diabetes Care Limited | 3 |
| Dexcom G7 GSS (155) | Dexcom, Inc. | 2 |
| Dexcom G6 Transmitter | Dexcom, Inc. | 2 |
| Dexcom G7 Sample Pack (160) | Dexcom, Inc. | 1 |
| Dexcom G6 Sensor Kit (1) Medicare | Dexcom, Inc. | 1 |
Showing 12 of 36. All products under Integrated Continuous Glucose Monitoring System, Factory Calibrated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261402 | 2026-06-08 |
| K253737 | 2026-02-03 |
| K253710 | 2025-12-17 |
| K243214 | 2025-04-09 |
| K240902 | 2024-04-23 |
| K234133 | 2024-02-26 |
| K231081 | 2023-05-15 |
| K223931 | 2023-01-11 |
| K213919 | 2022-12-07 |
| K221259 | 2022-07-29 |
| K201328 | 2021-07-15 |
| K200876 | 2020-12-04 |
| K191450 | 2019-06-28 |
| K183206 | 2019-02-14 |
| DEN170088 | 2018-03-27 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Dexcom, Inc. | 510(k) number | 2025-07-24 | Class I | Software design | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 o | 532821 |
| Dexcom, Inc. | 510(k) number | 2025-07-24 | Class I | Software design | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 o | 907842 |
| Dexcom, Inc. | 510(k) number | 2025-07-24 | Class I | Software design | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 o | 907842 |
| Dexcom, Inc. | 510(k) number | 2025-05-12 | Class I | Nonconforming Material/Component | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose v | 602,445 units |
Recalls
6 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-05-27 | Class II | Nonconforming Material/Component | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were | ||
| 2026-04-14 | Class II | Software design | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue u | 70212 | |
| 2026-04-14 | Class II | Software design | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue u | 58582 | |
| 2026-04-14 | Class II | Software design | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue u | 58582 | |
| 2025-08-28 | Class I | Software Design Change | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed de | 333 | |
| 2025-07-24 | Class I | Software design | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 o | 41629 | |
| 2025-07-24 | Class I | Software design | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 o | 39309 | |
| 2025-05-12 | Class I | Nonconforming Material/Component | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose v | 36,824 units | |
| 2025-05-12 | Class I | Nonconforming Material/Component | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose v | 38,127 units | |
| 2025-05-12 | Class I | Nonconforming Material/Component | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose v | 26,291 units | |
| 2025-05-05 | Class II | Software design | A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and t | 61,355 users | |
| 2025-01-27 | Class II | Software design | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system.net error occurs when an alar | ||
| 2025-01-27 | Class II | Software design | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system.net error occurs when an alar | ||
| 2025-01-27 | Class II | Software design | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system.net error occurs when an alar | ||
| 2020-02-03 | Class II | Under Investigation by firm | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. | 275583 | 2022-01-20 |
| 2019-11-19 | Class II | Software design | It was reported that the user’s low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. | 237888 users registered. | 2023-08-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.