# K080010: Nocc Hydrophilic Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kytogenics, Inc.
- Decided: Mar 14, 2008 after 71 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984264 (1999). 1 ancestor in all.
21 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984264: Modification of Bionect Clear Hydrogel, Fidia Pharmaceutical Corp. (1999) Summary page 1.

## Most influential descendants
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own
- K092689: Manukapli Wound Dressing (2010), 10 descendants of its own
- K112191: Healex Biosponge Wound Dressing (2012), 5 descendants of its own
- K123961: Sentrex Biosponge MPD (2013), 4 descendants of its own
- K121227: Manuka Fill (2012), 4 descendants of its own

## Indications for use
Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree bums.

Source page: https://510kreport.com/device/K080010
Methodology: https://510kreport.com/methodology