# K163556: MediClear PreOp

- Pathway: 510(k) (Traditional)
- Applicant: Covalontechnologies, Inc.
- Decided: Sep 14, 2017 after 269 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801550 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape, 3M Healthcare (2014) Summary page 4.
- K801550: 3M Germicidal Surgical Incise Drape, 3M Company (1981) Summary page 4.

## Indications for use
MediClear™ PreOp is indicated for use as a pre-operative (incision/insertion) drape that provides continuous antimicrobial activity to reduce the risk of contamination of the skin site by acting as an external barrier to microbial and other contamination. MediClear™ PreOp can be left on the preoperative incision site for up to 7 days. MediClear™ PreOp is intended to be used on intact skin and for external use only.

Source page: https://510kreport.com/device/K163556
Methodology: https://510kreport.com/methodology