# K140195: Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Griffith-Lucas, LLC
- Decided: Sep 10, 2014 after 226 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843496: Drape Surgical Utility Drape Sterile, Busse Hospital Disposables, Inc. (1984) Summary page 4.
- K082297: Busse Surgical Drape, Busse Hospital Disposables, Inc. (2008) Summary page 4.
- K083320: Dukal Surgical Drape; Fenestrated Dukal Surgical Drape, Dukal Corp. (2009) Summary page 4.

## Indications for use
The Surgical Drape is intended for external use only and is 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.

Source page: https://510kreport.com/device/K140195
Methodology: https://510kreport.com/methodology