# K171908: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Jul 11, 2017 after 15 days
- Product code: SEL (Securement Wound Dressing For Reduction Of Infection)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K895920 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063458: 3M Tegaderm CHG Dressing, 3M Company (2007) Summary page 5.
- K080620: Modification to 3M Tegaderm CHG Dressing, 3M Company-3M Health Care (2008) Summary page 5.
- K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing, 3M Company (2017) Summary page 5.

## Recalls of this device
- Aug 14, 2024 · Class II · Z-0038-2025: Contamination with foreign substance matter

## Indications for use
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering IV catheters, other intravascular catheters and percutaneous devices. Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.

Source page: https://510kreport.com/device/K171908
Methodology: https://510kreport.com/methodology