# K053095: Honey Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences Canada, Inc.
- Decided: Jul 12, 2007 after 616 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
No predicates in its family tree.
24 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072956: Medihoney Primary Dressings with Active Manuka Honey (2007), 23 descendants of its own
- K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey (2008), 16 descendants of its own
- K081584: Derma Sciences Otc Medihoney Dressings with Active Manuka Honey (2008), 14 descendants of its own
- K092689: Manukapli Wound Dressing (2010), 10 descendants of its own
- K083334: Elasto-Gel Manuka Honey Wound Dressing (2009), 5 descendants of its own

## Recalls of this device
- Jan 16, 2026 · Class II · Z-1364-2026: Potential packaging failures, which could lead to a breach in the sterile barrier.

## Indications for use
Under the supervision of a healthcare professional, API-MED ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as: * 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/K053095
Methodology: https://510kreport.com/methodology