# K133729: Wound Dressing with Manuka Honey

- Pathway: 510(k) (Traditional)
- Applicant: Manuka Health New Zealand, Ltd.
- Decided: Jan 23, 2015 after 413 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Wound Dressing with Manuka Honey is indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds and surgical wounds. For single-use only. Wound Dressing with Manuka Honey is indicated for minor cuts, minor abrasions, minor scalds, and minor burns. For single-use only.

Source page: https://510kreport.com/device/K133729
Methodology: https://510kreport.com/methodology