# K121919: Surgical Drape with Aami Liquid Barrier Level IV

- Pathway: 510(k) (Traditional)
- Applicant: Exact Medical Manufacturing, Inc.
- Decided: Feb 14, 2013 after 227 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: 3 generations back to K080629 (2008). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102666: Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 Claim, Kimberly-Clark Corp. (2010) Summary page 1.

## Indications for use
Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The EMM Surgical Drapes AAMI Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007.

Source page: https://510kreport.com/device/K121919
Methodology: https://510kreport.com/methodology