Panels › Clinical Chemistry › Product code QBJ · Class 2
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Regulation 862.1355
3510(k)s in 12 months (18 all time)
5recalls in 12 months (23 all time)
16recalls that name a 510(k)
Top companies in QBJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Dexcom, Inc. | 15 | 20 |
| Abbott Diabetes Care, Inc. | 3 | 0 |
| Cardinal Health Inc. | 0 | 1 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Medtronic Inc. | 0 | 1 |
| 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 |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Continuous Glucose Monitor (CGM) Open, Classified |
QBJ | None listed |
| 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 |
| Mar 16, 2021 | Cardinal Health Inc. DEXCOM G6 SENSOR 3 PACK
Item Number: 5447552 Open, Classified |
QBJ | K200876 |
| 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 |
| 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 |
| May 16, 2018 | Medtronic Inc. Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system
Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and contro Terminated |
QBJ | None listed |
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