510(k) · Cleared
Recalled · 2008Sterile Disposable Equipment Magnet Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contour Fabricators, Inc. · KKX Drape, Surgical, Antimicrobial
Cleared on Apr 10, 1997 as substantially equivalent to K782155 (Contour Fabricators, Inc., 1979) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1979. It has been recalled 5 times.
- Decided
- Apr 10, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- KKX
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K782155 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK782155 General Equipment CoverContour Fabricators, Inc. · 1979 · Recalled
- This deviceK970185 Sterile Disposable Equipment Magnet CoverContour Fabricators, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K782155 | General Equipment Cover | Contour Fabricators, Inc. | 1979 | 5 |
| 0 (this device) | K970185 | Sterile Disposable Equipment Magnet Cover | Contour Fabricators, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K782155 | General Equipment CoverSummary page 3…erile, Disposable Magnet Cover Sterile, Disposable Equipment Cover Contour Fabricators, Inc. Bandbag, Wrap, Sterile, Disposable Flouroscope and General Equipment Cover. K782155 Bemiss-Jason Corporation (originally Triad Medical Division), E- Z Fit Cover. K831287 The sterile, disposable magnet cover util… | 1979 |
| * | K831287 | E-Z FITSummary page 3…, Inc. Bandbag, Wrap, Sterile, Disposable Flouroscope and General Equipment Cover. K782155 Bemiss-Jason Corporation (originally Triad Medical Division), E- Z Fit Cover. K831287 The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which h… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2008 | Not classified | Z-1730-2009 | Release of Material/Component prior to receiving test results | 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 products. This issue could result in… |
| Aug 15, 2008 | Not classified | Z-1706-2009 | Packaging process control | 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 products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1708-2009 | Packaging process control | 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 products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1707-2009 | Packaging process control | 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 products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1709-2009 | Packaging process control | 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 products. This issue could result in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K782155.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970185: Sterile Disposable Equipment Magnet Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970185
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026