# FXX: Mask, Surgical

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 607
- 510(k) review time 2021–2025: median 150 days (middle half 91–228)
- Recalls: 8 (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)
- 2017: 1
- 2018: 3
- 2019: 4
- 2020: 27
- 2021: 218
- 2022: 91
- 2023: 22
- 2024: 15
- 2025: 6
- 2026: 5

## Most-cited predicates
- K153496: Disposable Surgical Face Mask (2016), cited by 40
- K160269: Surgical Face Masks (Ear loops and Tie-on) (2016), cited by 39
- K182515: Surgical Face Mask (2019), cited by 34
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks (2011), cited by 19
- K201479: DemeMASK (2020), cited by 13
- K200847: Surgical Face Mask (2020), cited by 11
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (2019), cited by 10
- K182514: Surgical Face Mask (2019), cited by 9
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model (2011), cited by 9
- K133070: SURGICAL FACE MASK (Ear Loops and Tie-on) (2015), cited by 9

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