# K980183: Promax Surgical Drapes and Covers

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: Feb 26, 1998 after 37 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 K923811 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923811: Compel Surgical Drapes, Standard Textile Co., Inc. (1993) Summary page 1.

## Indications for use
Promax urgicai Drapes and Covers are intended to be used in health care facilities on patients or surfaces during surgical procedures where protection from liquid migration is needed. The liquid barrier will inhibit migration of liquid through its surface.

Source page: https://510kreport.com/device/K980183
Methodology: https://510kreport.com/methodology