# K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Jun 19, 2008 after 14 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
Longest line of descent: 3 generations back to K053095 (2007). 12 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053095: Honey Alginate Dressing, Derma Sciences Canada, Inc. (2007) Summary page 1.
- K072956: Medihoney Primary Dressings with Active Manuka Honey, Derma Sciences, Inc. (2007) Summary page 1.
- K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008) Summary page 1.
- K991608: Dermaphylyx Calcium Alginate Wound Dressing, Dermaphylyx, Inc. (1999) Summary page 1.
- K053538: Modification to Phytacare Alginate Hydrogel Wound Filler, Curapharm, Inc. (2006) Summary page 1.
- K080010: Nocc Hydrophilic Wound Dressing, Kytogenics, Inc. (2008) Summary page 1.
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002) Summary page 2.

## Most influential descendants
- 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
- K173911: Medline Burn and Wound Dressing (2018), 2 descendants of its own

## Indications for use
For over the counter use, MEDIHONEY T M APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary-Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for non-exuding to moderately exuding wounds. All of the Medihoney Wound Dressings are intended for the management of the following: * 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/K081584
Methodology: https://510kreport.com/methodology