# FRO: Dressing, Wound, Drug

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 710
- 510(k) review time 2021–2025: median 263 days (middle half 166–366)
- Recalls: 40 (2 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: 23
- 2018: 20
- 2019: 16
- 2020: 12
- 2021: 8
- 2022: 9
- 2023: 18
- 2024: 24
- 2025: 11
- 2026: 17

## Most-cited predicates
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), cited by 17
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing (2008), cited by 15
- K981299: Silverlon Contact Wound Dressing (1998), cited by 13
- K013814: Absorbent Antimicrobial Wound Dressing (2002), cited by 12
- K042729: Dermacyn Wound Irrigation (2005), cited by 11
- K023612: Silverlon Contact Wound Dressing (2003), cited by 10
- K041316: Antimicrobial Alginate Dressing (2004), cited by 9
- K052643: Epiceram (2006), cited by 9
- K022670: Carraklenz and Ultraklenz (2002), cited by 9
- K001519: Acticoat 7 Dressing (2000), cited by 9

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