# PHN: Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 139 days (middle half 137–142)
- 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)
- 2014: 1
- 2022: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K242634: PuraStat (2025), cited by 2
- K213552: PuraStat-RM (2022), cited by 2
- K140558: Proctigard (2014), cited by 1
- K253923: PuraStat (2026), cited by 1

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