# K061422: Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Austin Medical, Inc.
- Decided: Sep 25, 2006 after 125 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 K864899 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864899: Surgical Drape Pack, Webster Enterprises, Inc. (1987) Summary page 1.

## Indications for use
Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.

Source page: https://510kreport.com/device/K061422
Methodology: https://510kreport.com/methodology