# FRL: Fiber, Medical, Absorbent

- Device class: 1; regulation: 21 CFR 880.5300; FDA's rule: 510(k) exempt
- FDA decisions: 19
- 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)
- 1977: 5
- 1978: 1
- 1979: 3
- 1980: 3
- 1981: 2
- 1991: 1
- 1993: 1
- 2006: 1
- 2011: 1
- 2013: 1

## Most-cited predicates
- K061615: Interdry Textile with Silver (2006), cited by 2
- K110715: Interdry Silver (2011), cited by 1

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