# K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Jul 25, 2014 after 175 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: 1 generation back to K801550 (1981). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801550: 3M Germicidal Surgical Incise Drape, 3M Company (1981) Summary page 1.

## Most influential descendants
- K222578: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (2023), 0 descendants of its own
- K163556: MediClear PreOp (2017), 0 descendants of its own

## Indications for use
3M Steri-Drape CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

Source page: https://510kreport.com/device/K140250
Methodology: https://510kreport.com/methodology