# K150985: Medihoney Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Nov 19, 2015 after 219 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914579 (1992). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101793: Medihoney Gel Dressing with Active Manuka Honey, Derma Sciences, Inc. (2011) Summary page 4.
- K131176: Ross RU Skin Discontinuities, Biotd S.A. (2014) Summary page 4.

## Recalls of this device
- Jan 16, 2026 · Class II · Z-1365-2026: Potential packaging failures, which could lead to a breach in the sterile barrier.

## Indications for use
Derma Sciences Medihoney Wound Gel helps maintain moist environment. Moist wound environment was shown to be conducive to wound healing. For over the counter use, Medihoney Wound Gel with Active Leptospermum Honey may be used for: -minor abrasions -lacerations -minor cuts -minor scalds and burns Under the supervision of a healthcare professional, Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing and are indicated for non-draining to moderately exuding wounds. The Medihoney Gel 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, traumatic and surgical wounds

Source page: https://510kreport.com/device/K150985
Methodology: https://510kreport.com/methodology