# K092212: Busse Surgical Drapes Iii

- Pathway: 510(k) (Special)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Oct 9, 2009 after 79 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 K031287 (2003). 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)
- K083424: Busse Surgical Drape, Busse Hosipital Disposables (2009) Summary page 1.

## Indications for use
The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424. The Drapes included in this submission are the following: 687 - Sterile Blue Laminated Non-Woven 22 x 25 Drape with 2 ¼4" Fenestration and Adhesive Patch 686 - Sterile Blue Laminated Non-Woven 22 x 25 Drape

Source page: https://510kreport.com/device/K092212
Methodology: https://510kreport.com/methodology