# K060200: Microtek Medical Warming Drape

- Pathway: 510(k) (Traditional)
- Applicant: Microtek Medical, Inc.
- Decided: May 31, 2006 after 125 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cincinnati Sub-Zero - Convective Air Warming Blankets: named in the summary without a submission number
- (no number) Nellcor (Tyco) Warmtouch Warming Blankets: named in the summary without a submission number

## Recalls of this device
- Apr 11, 2018 · Class II · Z-1964-2018: Product sterility may be compromised due to unsealed packaging.

## Indications for use
Microtek Medical, Inc. Patient Warming Drape is intended to be used to provide patient warming during a variety of surgeries or procedures in the clinical setting.

Source page: https://510kreport.com/device/K060200
Methodology: https://510kreport.com/methodology