# K970185: Sterile Disposable Equipment Magnet Cover

- Pathway: 510(k) (Traditional)
- Applicant: Contour Fabricators, Inc.
- Decided: Apr 10, 1997 after 83 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K782155 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K782155: General Equipment Cover, Contour Fabricators, Inc. (1979) Summary page 3.
- K831287: E-Z FIT, Triad Medical Division (1983) Summary page 3.

## Recalls of this device
- Aug 29, 2008 · Not classified · Z-1730-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the
- Aug 15, 2008 · Not classified · Z-1706-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product
- Aug 15, 2008 · Not classified · Z-1708-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product
- Aug 15, 2008 · Not classified · Z-1707-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product
- Aug 15, 2008 · Not classified · Z-1709-2009: GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the product

## Indications for use
The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination. This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.

Source page: https://510kreport.com/device/K970185
Methodology: https://510kreport.com/methodology