# MSH: Respirator, Surgical

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) exempt
- FDA decisions: 35
- 510(k) review time 2021–2025: median 112 days (middle half 112–112)
- 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)
- 2007: 7
- 2008: 2
- 2009: 2
- 2010: 4
- 2013: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2024: 1

## Most-cited predicates
- K960778: Isolair Apr Type N95 (1996), cited by 8
- K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks (2005), cited by 6
- K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S (2004), cited by 5
- K063023: 3M Health Care Particulate Respirator and Surgical Mask, Model 1870 (2007), cited by 4
- K061859: Inovel Health Care N95 Particulate Respirators & Surgical Masks (2006), cited by 3
- K070139: Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 (2007), cited by 2
- K974068: PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical (1997), cited by 2
- K121069: 3M Vflex Health Care Particulate Respirator and Surgical Mask (2013), cited by 1
- K062665: Inovel Health Care N95 Particulate Respirators and Surgical Masks (2006), cited by 1
- K070168: N95 Respirator, Models N9504C, N9504CS and N9514C (2007), cited by 1

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