510(k) · Cleared
ClearedPreclude Ima Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · MFX Vessel Guard Or Cover, To Facilitate Revision Surgeries
Cleared on May 23, 1996 after a 106-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- May 23, 1996
- Review
- 106 days
- Class
- Class II
- Product code
- MFX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK960532 Preclude Ima SleeveW. L. Gore & Associates, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK082782 Replication Medical Vessel GuardReplication Medical, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK103558 Synthes Scout Vessel GuardSynthes Spine · 2011
- Descendant · 2 generations on · 0 of its ownK111048 Synthes Scout Tack FixationSynthes Spine · 2012
- Descendant · cites it directly · 0 of its ownK100984 Xylos Vessel GuardXylos Corporation · 2010
- Descendant · cites it directly · 0 of its ownK090637 Cardio-WrapMast Biosurgery USA, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K082782Replication Medical Vessel GuardReplication Medical, Inc. · 2009 · cites it directly3descendants
- K103558Synthes Scout Vessel GuardSynthes Spine · 2011 · 2 generations on1descendant
- K111048Synthes Scout Tack FixationSynthes Spine · 2012 · 2 generations on0descendants
- K100984Xylos Vessel GuardXylos Corporation · 2010 · cites it directly0descendants
- K090637Cardio-WrapMast Biosurgery USA, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960532 | Preclude Ima Sleeve | W. L. Gore & Associates, Inc. | 1996 | — |
| +1 | K082782 | Replication Medical Vessel Guard | Replication Medical, Inc. | 2009 | — |
| +2 | K103558 | Synthes Scout Vessel Guard | Synthes Spine | 2011 | — |
| +2 | K111048 | Synthes Scout Tack Fixation | Synthes Spine | 2012 | — |
| +1 | K100984 | Xylos Vessel Guard | Xylos Corporation | 2010 | — |
| +1 | K090637 | Cardio-Wrap | Mast Biosurgery USA, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 MFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | PRECLUDE™ Pericardial Membrane Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082782 (Replication Medical, Inc., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MFX devicesMFX Vessel Guard Or Cover, To Facilitate Revision Surgeries: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MFX
FDA has decided no MFX device since 2007.
Median 510(k) review, days · MFX
Too few MFX 510(k)s in any year since 2007 to give a median.
Recalls per year · MFX
No recall names MFX since 2007.
Adverse event reports per year · MFX
1in 2010
MAUDE reports naming product code MFX, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use as a wrap for pedicled arterial conduits.
The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.
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/K960532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960532: Preclude Ima Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960532
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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