# K050322: Microtek Equipment Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Microtek Medical, Inc.
- Decided: May 17, 2005 after 97 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931417 (1995). 2 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 12 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 1.
- K931417: Sterile Equipment Covers, Custom Medical Products, Ltd. (1995) Summary page 1.

## Most influential descendants
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K081476: Surgical Concept Designs Positionor Surgical Drape (2008), 1 descendant of its own
- K052395: Sterile Equipment Covers (2005), 1 descendant of its own
- K141438: Whitney Medical Solutions Eshield (2014), 0 descendants of its own
- K131096: AR1000 Series Ultrasonic Wound Therapy System (2014), 0 descendants of its own

## Recalls of this device
- Mar 16, 2015 · Class II · Z-1385-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1387-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1382-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1389-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1391-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1381-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1386-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1388-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1383-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1384-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1393-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1380-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1390-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Mar 16, 2015 · Class II · Z-1392-2015: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Jul 19, 2013 · Class II · Z-1995-2013: Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm a
- Aug 23, 2010 · Not classified · Z-0592-2011: This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization.
- Jun 7, 2005 · Not classified · Z-1571-05: Customer observed unsealed packages.

## Indications for use
The intended use of this device is to protect equipment from contamination during a variety of procedures throughout the clinical setting.

Source page: https://510kreport.com/device/K050322
Methodology: https://510kreport.com/methodology