# K110546: Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Jul 27, 2011 after 152 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872165 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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.
- K053613: L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active, Theo Manufacturing BV (2007) Summary page 1.

## Most influential descendants
- K222143: Apis (R), Veris (TM) (2023), 0 descendants of its own

## Recalls of this device
- Aug 5, 2025 · Class II · Z-2508-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.
- Aug 5, 2025 · Class II · Z-2509-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.
- Aug 5, 2025 · Class II · Z-2510-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.
- Aug 5, 2025 · Class II · Z-2507-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.
- Aug 5, 2025 · Class II · Z-2511-2025: Packaging failures were identified which could lead to a breach in the sterile barrier.

## Indications for use
The Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey provides a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. For over the counter use, Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey may be used for: minor abrasions minor cuts minor scalds Minor burns Under the supervision of a healthcare professional, The Derma Sciences Medihoney Hydrogel Sheet Dressings provide a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. The Medihoney Hydrogel Sheet 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/K110546
Methodology: https://510kreport.com/methodology