# K063458: 3M Tegaderm CHG Dressing

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Apr 5, 2007 after 141 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: 2 generations back to K895920 (1991). 3 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 1.
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 1.

## Most influential descendants
- K080620: Modification to 3M Tegaderm CHG Dressing (2008), 7 descendants of its own
- K113836: Benehold CHG Transparent Film Dressing (10X12CM) (8.5X12CM) (6.5X7 CM) (2012), 4 descendants of its own
- K121819: Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (2012), 3 descendants of its own
- K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (2017), 1 descendant of its own
- K163529: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) (2017), 1 descendant 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 Dressings (Chlorhexidine Gluconate Securement Dressing), can be used to cover and protect catheter sites and to secure devices to skin. Common applications include IV catheters, other intravascular catheter and percutaneous devices.

Source page: https://510kreport.com/device/K063458
Methodology: https://510kreport.com/methodology