# OXZ: Pediatric/Child Facemask

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 418 days (middle half 397–489)
- 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)
- 2011: 1
- 2012: 1
- 2016: 1
- 2019: 1
- 2021: 2
- 2022: 2
- 2023: 1

## Most-cited predicates
- K160100: Prestige Ameritech Pediatric/Child’s Face mask (2016), cited by 3
- K113340: Kimberly-Clark Child's Facemask (2012), cited by 2
- K103150: Kimberly-Clark Child/Pediatric Face Mask (2011), cited by 1
- K210321: Dukal Corporation Level 1 Pediatric Face Mask (2022), cited by 1

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