# K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Mar 25, 2009 after 142 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K080629 (2008). 1 ancestor in all.
5 later devices descend from it; 4 cite 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)
- K080629: Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags, Promedical Products Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K093909: Busse Surgical Drapes IV (2010), 0 descendants of its own

## Recalls of this device
- Jul 17, 2025 · Class II · Z-2520-2025: Surgical drape packs may have open seals, which may compromise the sterility of the product.
- Nov 26, 2024 · Class II · Z-0983-2025: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

## Indications for use
Kimberly-Clark* Corporation intends to market the sterile KC100 Surgical Equipment Covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment. Kimberly-Clark* Corporation intends to market the sterile KC100 Surgical Drapes as devices 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/K083234
Methodology: https://510kreport.com/methodology