# FYC: Gown, Isolation, Surgical

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 68
- 510(k) review time 2021–2025: median 183 days (middle half 112–256)
- 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)
- 1998: 1
- 2001: 1
- 2016: 2
- 2017: 1
- 2018: 1
- 2020: 1
- 2021: 7
- 2022: 10
- 2023: 4
- 2024: 1

## Most-cited predicates
- K190306: AMD Ritmed AssureWear VersaGown (2020), cited by 5
- K160339: Cardinal Health Isolation Gown (2016), cited by 4
- K210785: Disposable Surgical Gowns (2021), cited by 3
- K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (2016), cited by 2
- K202310: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back (2021), cited by 2
- K171535: Surgical Isolation Gown (2018), cited by 1
- K925077: Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers (1993), cited by 1
- K952116: Cover Gown (1995), cited by 1
- K952115: Barrier Gown, Kool-Gard Backless Gown (1995), cited by 1
- K203415: Surgical Isolation Gown (2021), cited by 1

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