Company ยท US
Dexcom, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (7 in 12 months)
29recalls (4 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 35 |
| MDS | Sensor, Glucose, Invasive | 8 |
| QDK | Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | 4 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | 2 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | 2 |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | 1 |
| PJT | Continuous Glucose Monitor Secondary Display | 1 |
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | 1 |
| QDL | Integrated Continuous Glucose Monitoring System For Professional Retrospective Use | 1 |
| QII | Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | 1 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2026 | K262472 | Stelo Glucose Biosensor System Dexcom, Inc. | SBH |
| Jun 12, 2026 | K260935 | Stelo Glucose Biosensor System Dexcom, Inc. | SBH |
| Jun 8, 2026 | K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| May 21, 2026 | K261359 | Stelo Glucose Biosensor System Dexcom, Inc. | SAF |
| Feb 3, 2026 | K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Dec 17, 2025 | K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Nov 18, 2025 | K252818 | Dexcom Smart Basal Dexcom, Inc. | QRX |
| Apr 9, 2025 | K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Apr 23, 2024 | K240902 | Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Mar 5, 2024 | K234070 | Stelo Glucose Biosensor System Dexcom, Inc. | SAF |
| Feb 26, 2024 | K234133 | Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| May 15, 2023 | K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Jan 11, 2023 | K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Dec 7, 2022 | K213919 | Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Jul 29, 2022 | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) Syst Dexcom, Inc. | QBJ |
| Aug 17, 2021 | K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QDK |
| Jul 15, 2021 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QBJ |
| Dec 4, 2020 | K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Jan 29, 2020 | K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Dexcom, Inc. | QDK |
| Oct 25, 2019 | K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System Dexcom, Inc. | QDK |
| Oct 7, 2019 | K191833 | Dexcom G6 Pro Continuous Glucose Monitoring System Dexcom, Inc. | QII |
| Jun 28, 2019 | K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexco Dexcom, Inc. | QBJ |
| Feb 14, 2019 | K183206 | Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Nov 2, 2018 | K182405 | Dexcom Pro Q Continuous Glucose Monitoring System Dexcom, Inc. | QDL |
| Oct 26, 2018 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom, Inc. | QDK |
| Mar 27, 2018 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. | QBJ |
| Jan 23, 2015 | DEN140038 | Dexcom Share Direct Secondary Displays Dexcom, Inc. | PJT |
| Aug 19, 2014 | DEN140016 | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE Dexcom, Inc. | PHV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack
Model/Catalog Number: STP-AT-012
Software Version: N/A
Product Description: Dexco Open, Classified |
QBJ | K240902 |
| May 11, 2026 | Dexcom, Inc. Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System
Product Name: Dexcom ONE+ iOS CGM App
Model/Catalog Number: SW14244
Software Version: versions 1.5.0 and 1.6.0
Product Description: Dexcom Open, Classified |
QBJ | None listed |
| May 11, 2026 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM watchOS App
Model/Catalog Number: SW13355
Software Version: Versions 2.9.0 through 2.11.2
Product Description: De Open, Classified |
QBJ | K240902 K243214 |
| May 11, 2026 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM iOS App
Model/Catalog Number: SW12300
Software Version: Versions 2.9.0 through 2.11.2
Product Description: Dexcom Open, Classified |
QBJ | K240902 K243214 |
| Oct 30, 2025 | Dexcom, Inc. 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: Dex Open, Classified |
QBJ | K223931 |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System
Product Name: Dexcom ONE+ iOS CGM App
Model/Catalog Number: SW14244
Software Version: versions 1.4.0 and earlier
Product Description: Dexco Open, Classified |
QBJ | None listed |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System
Product Name: Dexcom ONE+ Android CGM App
Model/Catalog Number: SW14245
Software Version: versions 1.4.0 and earlier
Product Description: D Open, Classified |
QBJ | None listed |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM watchOS App
Model/Catalog Number: SW13355
Software Version: versions 2.8.0 and earlier
Product Description: Dexco Open, Classified |
QBJ | K213919 |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM iOS App
Model/Catalog Number: SW12300
Software Version: version 2.8.0 and earlier
Product Description: Dexcom G7 Open, Classified |
QBJ | K213919 |
| Sep 4, 2025 | Dexcom, Inc. Brand Name: Dexcom G7 Continuous Glucose Monitoring System
Product Name: Dexcom G7 CGM Android App
Model/Catalog Number: SW12299
Software Version: version 2.8.0 and earlier
Product Description: Dexcom Open, Classified |
QBJ | K213919 |
| Jun 16, 2025 | Dexcom, Inc. Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1),
STK-DO-013 (MT27409-1),
STK-DO-103 (MT27409-2),
STK-DO-109 (MT27409-2) Open, Classified |
QBJ | None listed |
| Jun 16, 2025 | Dexcom, Inc. Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2) Open, Classified |
QBJ | None listed |
| Jun 16, 2025 | Dexcom, Inc. Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT Open, Classified |
QBJ | K213919 |
| Jun 16, 2025 | Dexcom, Inc. Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) Open, Classified |
QBJ | K223931 |
| Jun 4, 2025 | Dexcom, Inc. Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system Open, Classified |
QBJ | K231081 |
| Feb 20, 2025 | Dexcom, Inc. Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 Open, Classified |
QBJ | K223931 |
| Feb 20, 2025 | Dexcom, Inc. Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 Open, Classified |
QBJ | K223931 |
| Feb 20, 2025 | Dexcom, Inc. Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 Open, Classified |
QBJ | K223931 |
| Feb 3, 2020 | Dexcom Inc Dexcom G6 Continuous Glucose Monitoring System
The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in perso Terminated |
QBJ | K191450 |
| Feb 3, 2020 | Dexcom Inc Dexcom G5 Continuous Glucose Monitoring System
The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in perso Terminated |
PQF | None listed |
| Feb 3, 2020 | Dexcom Inc Dexcom G4 PLATINUM Continuous Glucose Monitoring System
The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns Terminated |
MDS | None listed |
| Nov 19, 2019 | Dexcom Inc Brand Name: Dexcom G6 CGM App for iOS
Software Number: SW11677
Software Version: Version 1.4.0 up to corrected Version 1.4.4
GUDID Registered GTIN: 00386270000804 Terminated |
QBJ | K191450 |
| Jul 12, 2019 | Dexcom Inc Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determi Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom Inc Dexcom G5 Mobile Receiver
Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK,
Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue.
Intended to detect trends and track glucose p Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom Inc Dexcom G4 PLATINUM (Pediatric) Receiver with Share
Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom Inc Dexcom G4 PLATINUM Receiver with Share
Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK,
Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue.
Intended to detect trends and tr Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom Inc Dexcom G4 PLATINUM (Professional) Receiver
Receiver Part Number: MT20649 Receiver (mg/dL), Black.
Intended to detect trends and track glucose patterns in persons with diabetes.
The G4 PLATINUM CGM S Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom Inc Dexcom G4 PLATINUM (Pediatric) Receiver
Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pedia Terminated |
MDS | None listed |
| Apr 11, 2016 | Dexcom Inc Dexcom G4 PLATINUM Receiver
Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue.
Intended to detect trends and track glucose Terminated |
MDS | None listed |