# KOZ: Beads, Hydrophilic, For Wound Exudate Absorption

- Device class: 1; regulation: 21 CFR 878.4018; FDA's rule: 510(k) exempt
- FDA decisions: 22
- 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)
- 1978: 1
- 1980: 1
- 1982: 1
- 1984: 1
- 1985: 1
- 1987: 4
- 1988: 2
- 1989: 2
- 1990: 4
- 1991: 4

## Most-cited predicates
- K905069: Iodosorb Gel (1991), cited by 3
- K834343: Comfeel Powder (1984), cited by 1
- K905688: Cutinova Hydro (1991), cited by 1

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