# K101793: Medihoney Gel Dressing with Active Manuka Honey

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Feb 22, 2011 after 239 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K053095 (2007). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008) Summary page 1.
- K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey, Derma Sciences, Inc. (2008) Summary page 1.
- K072956: Medihoney Primary Dressings with Active Manuka Honey, Derma Sciences, Inc. (2007)
- K053095: Honey Alginate Dressing, Derma Sciences Canada, Inc. (2007) Summary page 1.

## Most influential descendants
- K150676: L-Mesitran Dressing Family II- Soft and Tulle (2015), 0 descendants of its own
- K150985: Medihoney Wound Gel (2015), 0 descendants of its own

## Recalls of this device
- Jan 16, 2026 · Class II · Z-1363-2026: Potential packaging failures, which could lead to a breach in the sterile barrier.
- Jan 10, 2025 · Class II · Z-1168-2025: Potential that the induction seal is not completely sealed to the device tube packaging.
- May 25, 2022 · Class III · Z-1803-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi
- Mar 6, 2018 · Class II · Z-1630-2018: Incorrect gel part number listed in a master manufacturing record

## Indications for use
The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, Medihoney Gel 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 Medihoney Gel Dressings provide a moist environment conducive to wound healing and are indicated for light to moderate 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 fill thickness) 1st and 2nd degree partial thickness burns * donor sites, and traumatic and surgical wounds.

Source page: https://510kreport.com/device/K101793
Methodology: https://510kreport.com/methodology