# K121436: Das Medical Equipment Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Das Medical, LLC
- Decided: Jun 6, 2013 after 387 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 K931417 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032065: Medline Band Bags and Equipment Covers, Medline Industries, Inc. (2003) Summary page 2.
- K052395: Sterile Equipment Covers, Volcano Corporation (2005) Summary page 2.

## Indications for use
The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact.

Source page: https://510kreport.com/device/K121436
Methodology: https://510kreport.com/methodology