# K042131: Promedical Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Promedical Products Co., Ltd.
- Decided: Dec 10, 2004 after 123 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 K964142 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021864: Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142), Primeline Medical Products, Inc. (2002) Summary page 2.
- K964142: Medline Disposable Surgical Drapes and Gowns, Medline Industries, Inc. (1997) Summary page 2.

## Indications for use
proMedical Products Co. LTD intends to market Non-sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination

Source page: https://510kreport.com/device/K042131
Methodology: https://510kreport.com/methodology