# K024054: Xylos Xcell Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Xylos Corporation
- Decided: Mar 7, 2003 after 88 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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: 2 generations back to K970566 (1997). 7 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990530: Kerlix MD Antimicrobial Gauze Dressing, The Kendall Company, L.P. (2000) Summary page 1.
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002)
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999) Summary page 1.
- K974251: X-Cell Wound Dressing, Xylos Corporation (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K011379: XYLOSTMXCellB Wound Dressing. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K051647: Fortaderm Antimicrobial Wound Dressing (2005), 3 descendants of its own
- K050032: Euromed Sureskin Iii with Silver Wound Dressings (2006), 2 descendants of its own
- K251582: Redermax Antibacterial Wound Matrix (2026), 1 descendant of its own
- K081274: Sureskin Silver Bandages (2008), 1 descendant of its own
- K261646: Redermax® Antibacterial Wound Matrix (2026), 0 descendants of its own

## Indications for use
The XCellB Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCellB Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain. Under the supervision of a health care professional, the XCell@Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions. The device is intended for one-time use.

Source page: https://510kreport.com/device/K024054
Methodology: https://510kreport.com/methodology