# K012807: Modification to: Compel Surgical Drapes

- Pathway: 510(k) (Special)
- Applicant: Standard Textile Co., Inc.
- Decided: Oct 11, 2001 after 50 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
ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures. ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective patient coverings, such as to isolate a site of surgical incision from microbial and other contamination. ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. The ComPel Surgical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Source page: https://510kreport.com/device/K012807
Methodology: https://510kreport.com/methodology