# NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

- Device class: 1; regulation: 21 CFR 878.4022; FDA's rule: 510(k) exempt
- FDA decisions: 29
- Recalls: 3 (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)
- 1991: 1
- 1992: 5
- 1993: 3
- 1994: 6
- 1995: 4
- 1996: 1
- 1997: 2
- 1999: 2
- 2008: 2
- 2009: 1

## Most-cited predicates
- K073246: Zenieva (2008), cited by 3
- K914207: Clearsite (R) Sterile Wound Care Dressing (1991), cited by 1
- K926508: Intrasite Gel (1993), cited by 1
- K920677: Clearsite Hydrogel Wound Dressing Modification (1992), cited by 1
- K083721: Modification to Zenieva (2009), cited by 1
- K950412: Curagel Hydrogel Wound Dressing (1995), cited by 1
- K082865: Modification to Zenieva (2008), cited by 1

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