# K964468: Iamin Wet Dressing (Copper-Saline)

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Feb 3, 1997 after 89 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dermagran Wet Dressing (Zinc-Saline): named in the summary without a submission number
- (no number) MPM Wet Dressings (Saline): named in the summary without a submission number
- (no number) lamin Hydrating Gel: named in the summary without a submission number
- (no number) CarraGauze Hydrogel Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K180643: MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) (2018), 1 descendant of its own
- K231088: Copper Foam Dressing (Prescription and OTC) (2024), 0 descendants of its own

## Recalls of this device
- Mar 26, 2015 · Class II · Z-1516-2015: The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these d

## Indications for use
A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient’s skin, provide a moist wound environment, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.

Source page: https://510kreport.com/device/K964468
Methodology: https://510kreport.com/methodology