# K130404: Tiburon Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jul 5, 2013 after 136 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
- K141324: Hongyu Disposable Surgical Drapes (2015), 0 descendants of its own

## Indications for use
Cardinal Health Tiburon® surgical drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only. This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Source page: https://510kreport.com/device/K130404
Methodology: https://510kreport.com/methodology