Class Class II
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K223931)
Description
Dexcom G6 Continuous Glucose Monitoring (CGM) System by Dexcom, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223931
Clearance Date2023-01-11
Clearance TypeSpecial
Product CodeQBJ
Regulation Number862.1355
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223931
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Dexcom G6 Continuous Glucose Monitoring (CGM) System (K223931) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213919 | Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | 2022 |
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexco... | Dexcom, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | 2023 |
Trace the full predicate network for K223931
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.