# K101598: Emm Surgical Drape SMS W/PE Sides Model 13-005 (with Minor Dimensional Variations for Alternate Configurations)

- Pathway: 510(k) (Traditional)
- Applicant: Exact Medical Manufacturing, Inc.
- Decided: Oct 4, 2010 after 118 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 K021864 (2002). 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)
- K021864: Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142), Primeline Medical Products, Inc. (2002) Summary page 1.

## Indications for use
Exact Medical Manufacturing Surgical Drape SMS w/PE Sides 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 Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Source page: https://510kreport.com/device/K101598
Methodology: https://510kreport.com/methodology