# K200835: 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 4, 2020 after 157 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: 4 generations back to K895920 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123679: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Port Dressing, 3M Company (2013) Summary page 5.

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

## Indications for use
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad can be used to cover and protect catheter sites. Common applications include covering intravascular catheters and percutaneous devices.

Source page: https://510kreport.com/device/K200835
Methodology: https://510kreport.com/methodology