# QOG: Injection Data Capture Device

- Device class: 2; regulation: 21 CFR 880.5860; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 90 days (middle half 46–229)
- 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)
- 2022: 2
- 2024: 2
- 2025: 3

## Most-cited predicates
- K222689: Mallya Injection Pen Adapter (Mallya® for Solostar®) (2022), cited by 2
- K231820: SoloSmart Injection Pen Adapter (SoloSmart®) (2024), cited by 1
- K212217: Tempo Smart Button (2022), cited by 1
- K250555: MallyaD injection pen adapter (MallyaD) (2025), cited by 1

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