# K133279: Medihoney Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Jun 25, 2015 after 609 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008) Summary page 6.

## Indications for use
Medihoney Calcium Alginate Dressing with Active Leptospermum Honey are indicated for the management of moderate to heavily exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These 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 • traumatic and surgical wounds Medihoney Adhesive and Non-Adhesive Honeycolloid Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These 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 • traumatic and surgical wounds Medihoney Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These 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 • traumatic and surgical wounds Medihoney Gel Dressing with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These 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 • traumatic and surgical wounds The Medihoney Adhesive and Non-Adhesive Hydrogel Colloidal Sheet with Leptospermum Honey are indicated for the management of non-draining to lightly exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These 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 • traumatic and surgical wounds

Source page: https://510kreport.com/device/K133279
Methodology: https://510kreport.com/methodology