# K982234: AL-Gen Calcium Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Technologies, Ltd.
- Decided: Sep 8, 1998 after 75 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K853781: Unitron Model UM60-PP, Unitron Industries, Inc. (1985). Our OCR of the scanned summary read K853781, FDA’s number for Unitron Model UM60-PP (Unitron Industries, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1.

## Indications for use
Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.

Source page: https://510kreport.com/device/K982234
Methodology: https://510kreport.com/methodology