# SAF: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter

- Device class: 2; regulation: 21 CFR 862.1355; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 74 days (middle half 70–136)
- Recalls: 0 (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)
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K234070: Stelo Glucose Biosensor System (2024), cited by 3

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