# K251866: Tegaderm Post-Op Transparent Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Solventum US, LLC
- Decided: Oct 10, 2025 after 115 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K895920 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163529: ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm), Avery Dennison Corporation (2017) Summary page 5.

## Indications for use
The Tegaderm™ Post-Op Transparent Antimicrobial Dressing is a waterproof, single use, sterile dressing with Chlorhexidine Gluconate (CHG), intended to be used on adult patients by healthcare professionals to cover and protect closed surgical incisions or laparoscopic incision and a percutaneous device(s) (e.g., sutures, staples, tissue adhesives).

Source page: https://510kreport.com/device/K251866
Methodology: https://510kreport.com/methodology