# OSN: Software For Diagnosis/Treatment

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 65 days (middle half 65–65)
- Recalls: 2 (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)
- 2014: 1
- 2018: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K140550: Orthohub External Fixator Software (2014), cited by 2
- K180539: Deformity Analysis and Correction Software (DACS) and Instrumentation (2018), cited by 1

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