Dexcom, Inc.
Medical device manufacturer in San Diego, CA.
25510(k) clearances
2PMA approvals
29recalls
Device types
- QBJ Integrated Continuous Glucose Monitoring… 14
- QDK Integrated Continuous Glucose Monitoring… 4
- SAF Integrated Continuous Glucose Monitor For… 2
- SBH Integrated Continuous Glucose Monitor For… 2
- QDL Integrated Continuous Glucose Monitoring… 1
- QII Integrated Continuous Glucose Monitoring… 1
- QRX Continuous Glucose Monitor Informed Insulin… 1
510(k) clearances
| 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 |
| K234133 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Traditional | 02/26/2024SE |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) SystemQBJ · Special | 05/15/2023SE |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ · Special | 01/11/2023SE |
| K213919 | Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Traditional | 12/07/2022SE |
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program…QBJ · Special | 07/29/2022SE |
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemQDK · Traditional | 08/17/2021SE |
| K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ · Traditional | 07/15/2021SE |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…QBJ · Traditional | 12/04/2020SE |
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemQDK · Special | 01/29/2020SE |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemQDK · Special | 10/25/2019SE |
| K191833 | Dexcom G6 Pro Continuous Glucose Monitoring SystemQII · Traditional | 10/07/2019SE |
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous…QBJ · Special | 06/28/2019SE |
| K183206 | Dexcom G6 Continuous Glucose Monitoring SystemQBJ · Traditional | 02/14/2019SE |
| K182405 | Dexcom Pro Q Continuous Glucose Monitoring SystemQDL · Traditional | 11/02/2018SE |
| K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemQDK · Traditional | 10/26/2018SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2574-2026 Class II | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US…Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen… | 05/27/2026Open, Classified |
| Z-2165-2026 Class II | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for… | 04/14/2026Open, Classified |
| Z-2164-2026 Class II | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for… | 04/14/2026Open, Classified |
| Z-2163-2026 Class II | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for… | 04/14/2026Open, Classified |
| Z-0318-2026 Class I | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and…A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly… | 08/28/2025Open, Classified |
| Z-2450-2025 Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2449-2025 Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2448-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2447-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-2446-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | 07/24/2025Open, Classified |
| Z-1946-2025 Class I | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |
| Z-1945-2025 Class I | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |
| Z-1944-2025 Class I | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |
| Z-1943-2025 Class I | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |
| Z-1906-2025 Class II | Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7…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… | 05/05/2025Open, Classified |
| Z-1204-2025 Class II | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose… | 01/27/2025Open, Classified |
| Z-1203-2025 Class II | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose… | 01/27/2025Open, Classified |
| Z-1202-2025 Class II | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose… | 01/27/2025Open, Classified |
| Z-1562-2020 Class II | Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose…The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may… | 02/03/2020Terminated |
| Z-1561-2020 Class II | Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose…The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may… | 02/03/2020Terminated |
| Z-1560-2020 Class II | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM…The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may… | 02/03/2020Terminated |
| Z-1104-2020 Class II | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version…It was reported that the user's low alarm feature on the iOS application were not properly alerting users… | 11/19/2019Terminated |
| Z-0929-2020 Class II | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version…It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have… | 07/12/2019Terminated |
| Z-1339-2016 Class I | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1338-2016 Class I | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1337-2016 Class I | Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL)…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1336-2016 Class I | Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1335-2016 Class I | Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL)…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |
| Z-1334-2016 Class I | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black…Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | 02/23/2016Terminated |