# K990530: Kerlix MD Antimicrobial Gauze Dressing

- Pathway: 510(k) (Traditional)
- Applicant: The Kendall Company, L.P.
- Decided: Jan 31, 2000 after 346 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895993 (1990). 2 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895993: Vitapatch Antimicrobial Catheter Securement Device, Vitaphore Corp. (1990) Summary page 1.
- K973657: Arglaes-AB  Antimicrobial Barrier Island Dressing, Maersk Medical, Ltd. (1997) Summary page 1.

## Most influential descendants
- K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 (2007), 7 descendants of its own
- K024054: Xylos Xcell Antimicrobial Dressing (2003), 7 descendants of its own
- K121522: Polyfit Absorbing Antimicrobial Dressings (Otc) (2012), 5 descendants of its own
- K130857: Prontosan Wound Gel X (2013), 3 descendants of its own
- K051647: Fortaderm Antimicrobial Wound Dressing (2005), 3 descendants of its own

## Recalls of this device
- Aug 1, 2018 · Class II · Z-0013-2019: Potential for product sterility breach due to a compromised or pinched seal defect
- Aug 1, 2018 · Class II · Z-0014-2019: Potential for product sterility breach due to a compromised or pinched seal defect
- Aug 1, 2018 · Class II · Z-0017-2019: Potential for product sterility breach due to a compromised or pinched seal defect
- Aug 1, 2018 · Class II · Z-0018-2019: Potential for product sterility breach due to a compromised or pinched seal defect
- Aug 1, 2018 · Class II · Z-0015-2019: Potential for product sterility breach due to a compromised or pinched seal defect
- Aug 1, 2018 · Class II · Z-0016-2019: Potential for product sterility breach due to a compromised or pinched seal defect
- Jan 8, 2004 · Not classified · Z-0380-04: Sterility compromised due to lack of package seal integrity

## Indications for use
KERLIX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing

Source page: https://510kreport.com/device/K990530
Methodology: https://510kreport.com/methodology