# DEN140016: Continuous Glucose Monitor Retrospective Data Analysis Software

- Pathway: De Novo
- Applicant: unknown
- Decided: —
- Product code: PHV (Continuous Glucose Monitor Retrospective Data Analysis Software)
- Device class: 1
- Regulation: 21 CFR 862.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

Source page: https://510kreport.com/device/DEN140016
Methodology: https://510kreport.com/methodology