# K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Apr 23, 2008 after 77 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K053095 (2007). 2 ancestors in all.
16 later devices descend from it; 4 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)
- K072956: Medihoney Primary Dressings with Active Manuka Honey, Derma Sciences, Inc. (2007) Summary page 1.
- K053095: Honey Alginate Dressing, Derma Sciences Canada, Inc. (2007) 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
- K121227: Manuka Fill (2012), 4 descendants of its own
- K131796: Manuka Fill Wound Dressing (2014), 3 descendants of its own
- K102659: Manukahd, Manukahd Rope, Manukahd Border (2010), 3 descendants of its own

## Recalls of this device
- Aug 5, 2025 · Class II · Z-2506-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.
- Aug 5, 2025 · Class II · Z-2505-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.
- Sep 13, 2024 · Class II · Z-0054-2025: There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

## Indications for use
The Derma Sciences Medihoney Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and is indicated for the management of light to moderately exuding wounds such as: · diabetic foot ulcers * leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) · pressure ulcers / sores (partial and full thickness) · 1st and 2nd degree partial thickness burns · donor sites, and traumatic and surgical wounds.

Source page: https://510kreport.com/device/K080315
Methodology: https://510kreport.com/methodology