# K123679: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Feb 28, 2013 after 90 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 3 generations back to K895920 (1991). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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). Our reading of the summary gave K061458, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Tegaderm CHG Dressing (Chlorhexidine Gluconate Securement Dressing)”.

## Most influential descendants
- K200835: 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad (2020), 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 IV. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.

Source page: https://510kreport.com/device/K123679
Methodology: https://510kreport.com/methodology