# K112549: IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver

- Pathway: 510(k) (Traditional)
- Applicant: Covalontechnologies, Inc.
- Decided: May 4, 2012 after 246 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: 4 generations back to K895920 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080620: Modification to 3M Tegaderm CHG Dressing, 3M Company-3M Health Care (2008) Summary page 1.
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 1.
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999) Summary page 1.
- (no number) Mepitac Soft Silicone Tape: named in the summary without a submission number

## Indications for use
IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.

Source page: https://510kreport.com/device/K112549
Methodology: https://510kreport.com/methodology