# K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 15, 2017 after 537 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: 4 generations back to K895920 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 5.

## Most influential descendants
- K171908: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (2017), 0 descendants of its own

## 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 I.V. 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/K153410
Methodology: https://510kreport.com/methodology