# K143124: KA01 Chitosan Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Foshan United Medical Technologies, Ltd.
- Decided: Jan 26, 2015 after 87 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: 6 generations back to K914575 (1991). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070175: Aquanova Super-Absorbent Gelling Dressing, Otc, Medtrade Products, Ltd. (2007) Summary page 5.
- K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2007) Summary page 5.

## Most influential descendants
- K212766: Maxiocel Chitosan Wound Dressing (2023), 0 descendants of its own
- K172010: gel-e Bandage (2017), 0 descendants of its own

## Indications for use
The KAO1 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for the management of? Pressure sores Diabetic ulcers Leg ulcers Donor sites and Graft sites Surgical wounds Skin abrasions and lacerations 1st and 2nd degree burns Trauma wounds The KAO01 Chitosan Wound Dressing may be used for the management of: Minor cuts Minor scalds and 1st degree burns Abrasions Lacerations

Source page: https://510kreport.com/device/K143124
Methodology: https://510kreport.com/methodology