# QHJ: Sensor, Glucose, Implanted, Non-Adjunctive Use

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 0
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2019: 6
- 2020: 1
- 2022: 3
- 2023: 5
- 2025: 1

## Most-cited predicates

Source page: https://510kreport.com/product-code/QHJ
Data by year (CSV): https://510kreport.com/product-code/QHJ.csv