# K020393: Master & Frank Surgical Drapes (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Master & Frank Enterprses Co., Ltd.
- Decided: May 3, 2002 after 86 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964142 (1997). 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)
- K964142: Medline Disposable Surgical Drapes and Gowns, Medline Industries, Inc. (1997) Summary page 3.

## Most influential descendants
- K062480: Joykey Surgical Drapes (Sterile) (2007), 0 descendants of its own

## Recalls of this device
- Feb 27, 2026 · Class II · Z-1889-2026: Unapproved design changes to the products outside of the 510(k) clearance.

## Indications for use
Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..

Source page: https://510kreport.com/device/K020393
Methodology: https://510kreport.com/methodology