# K080497: Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell AG)

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences Canada, Inc.
- Decided: Jun 27, 2008 after 126 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: 1 generation back to K052536 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052536: Algicell AG, Derma Sciences Canada, Inc. (2006) Summary page 1.

## Recalls of this device
- May 25, 2022 · Class III · Z-1800-2022: 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

## Indications for use
For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for: - abrasions - minor lacerations - minor cuts - minor scalds and burns Under the supervision of a healthcare professional, Algicell®Ag (Calcium Alginate Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as: * diabetic foot ulcer * leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology * pressure ulcers/sores (partial and full thickness) * donor sites, and traumatic and surgical wounds.

Source page: https://510kreport.com/device/K080497
Methodology: https://510kreport.com/methodology