# OLR: Oral Wound Dressing

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 215 days (middle half 112–244)
- Recalls: 1 (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)
- 2012: 1
- 2014: 1
- 2018: 1
- 2019: 2
- 2020: 2
- 2021: 2
- 2022: 2
- 2023: 1
- 2025: 3
- 2026: 4

## Most-cited predicates
- K013056: Gelclair Concentrated Oral Gel (2001), cited by 9
- K063148: Sock IT! Oral Pain Gel (2007), cited by 4
- K964852: Radiacare Oral Wound Rinse (1997), cited by 4
- K023155: Aloclair Oral Rinse (2002), cited by 4
- K012126: The Salicept Oral Patch (2001), cited by 3
- K040950: Aloclair Oral Gel (2004), cited by 2
- K024180: Oramagicrx Oral Wound Rinse (2003), cited by 2
- K983182: Aloe Therapy Oral Rinse (1998), cited by 2
- K933741: Carrasyn Oral Wound Dressing (1994), cited by 2
- K953423: Casrrasyn Oral Wound Dressing (1995), cited by 2

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