# K033164: Abram's Multi-Density Polyurethane Foam Wound Dressing System

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Len'S Medical Products, LLC
- Decided: Sep 7, 2004 after 343 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K946245 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002129: Ferris Polymem Sterile Wound Dressing with Collagen, Ferris Mfg. Corp. (2000) Summary page 1.
- K022416: Contreet Foam Adhesive/Non-Adhesive, Coloplast Corp. (2003) Summary page 1.

## Indications for use
This device is indicated for use for the treatment of pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds (abrasions, lacerations, second degree burns) and draining wounds.

Source page: https://510kreport.com/device/K033164
Methodology: https://510kreport.com/methodology