# K052395: Sterile Equipment Covers

- Pathway: 510(k) (Traditional)
- Applicant: Volcano Corporation
- Decided: Dec 1, 2005 after 92 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: 2 generations back to K931417 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050322: Microtek Equipment Drapes, Microtek Medical, Inc. (2005) Summary page 1.
- K032065: Medline Band Bags and Equipment Covers, Medline Industries, Inc. (2003) Summary page 1.
- K961699: Equipment Covers, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.

## Most influential descendants
- K121436: Das Medical Equipment Drapes (2013), 0 descendants of its own

## Recalls of this device
- Feb 5, 2016 · Class II · Z-1041-2016: Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product b
- Feb 5, 2016 · Class II · Z-1042-2016: Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product b

## Indications for use
The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

Source page: https://510kreport.com/device/K052395
Methodology: https://510kreport.com/methodology