# K973283: Alginate/Zinc Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: Oct 21, 1997 after 49 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913344 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913344: Dermagran Wet Dressing (Zinc-Saline), Derma Sciences, Inc. (1992) Summary page 1.
- K953781: Innovative Technologies Calcium Alginate Wound Dressings, Innovative Technologies, Ltd. (1995) Summary page 1.

## Indications for use
Innovative Technologies Alginate / Zinc Wound Dressings may be used for the management of moderate to heavily exuding partial to full thickness wounds such as: Pressure Ulcers Arterial Ulcers Venous Ulcers Diabetic Ulcers 1st & 2nd Degree Bums Donor Sites Trauma Wounds Dermal Lesions

Source page: https://510kreport.com/device/K973283
Methodology: https://510kreport.com/methodology