# K083424: Busse Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hosipital Disposables
- Decided: Feb 26, 2009 after 99 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 K031287 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031287: Steri-Drape Surgical Drapes, 3M Company (2003) Summary page 1.

## Most influential descendants
- K092212: Busse Surgical Drapes Iii (2009), 0 descendants of its own

## 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' There are various models of drapes: Non-woven drapes, Tissue-Poly-tissue Drape, & SMS Drapes with round, oval & square fenestration shapes.

Source page: https://510kreport.com/device/K083424
Methodology: https://510kreport.com/methodology