# ONT: N95 Respirator With Antimicrobial/Antiviral Agent

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold (2009), cited by 2
- K090414: Spectrashield 9500 Surgical Mask (2011), cited by 1
- K120244: Spectrashield 9500 Surgical N95 Respirator (2012), cited by 1
- K122702: Biofriend Biomask N95 Surgical Respirator (2013), cited by 1

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