# K103106: Chlorashield TM Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion 213, LLC
- Decided: Mar 30, 2011 after 161 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 K895920 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 4.
- K063458: 3M Tegaderm CHG Dressing, 3M Company (2007) Summary page 4.

## Indications for use
The ChloraShieldrTM Antimicrobial Dressing is intended for use as a wound dressing to absorb exudate and to cover and protect catheter sites. Common applications include IV catheters, other intravascular catheters and percutaneous devices.

Source page: https://510kreport.com/device/K103106
Methodology: https://510kreport.com/methodology