# K080629: Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags

- Pathway: 510(k) (Traditional)
- Applicant: Promedical Products Co., Ltd.
- Decided: Oct 20, 2008 after 229 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100 (2009), 5 descendants of its own
- K102666: Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 Claim (2010), 1 descendant of its own
- K121919: Surgical Drape with Aami Liquid Barrier Level IV (2013), 0 descendants of its own
- K111458: Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers (2011), 0 descendants of its own
- K101689: Emm Equipment Cover-Polythylene (2010), 0 descendants of its own

## Indications for use
proMedical Products Co. LTD intends to market 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. proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover sutqical equipment and provide a protective barrier for that equipment.

Source page: https://510kreport.com/device/K080629
Methodology: https://510kreport.com/methodology