# K033900: X-Static Silverseal Hydrocolloid Film and Island Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Noble Fiber Technologies
- Decided: Jan 14, 2005 after 394 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 K970566 (1997). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999). Our reading of the summary gave K990310, FDA’s number for Charter Medical, LTD MP 450 (40 Micron Filter) (Charter Medical, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Arqlaes Film Dressing”.
- K001519: Acticoat 7 Dressing, Westaim Biomedical, Inc. (2000) Summary page 1.
- K982893: 3M Tegasorb Hydrocolloid Dressing, 3M Company (1998) Summary page 1.
- K983303: Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound Dressings, Innovative Technologies, Ltd. (1998) Summary page 1.
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM), Coloplast Corp. (2002) Summary page 1.

## Most influential descendants
- K072378: Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625, AR-1626 (2007), 1 descendant of its own
- K083007: Prowick (2009), 0 descendants of its own

## Indications for use
X-Static Silverseal Hydrocolloid Film and Island Dressings are indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.

Source page: https://510kreport.com/device/K033900
Methodology: https://510kreport.com/methodology