510(k) · Cleared
ClearedGore Preclude Vessel Guard
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 Aug 7, 2006 as substantially equivalent to K984526 (W. L. Gore & Associates, Inc., 1999) after a 49-day review. Its family tree reaches back 2 generations to 1981. 6 later devices descend from it.
- Decided
- Aug 7, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- MFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811841 (1981). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
- 1 generation backK984526 Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc. · 1999
- This deviceK061727 Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK082782 Replication Medical Vessel GuardReplication Medical, Inc. · 2009
- Descendant · cites it directly · 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 ownK101805 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK100984 Xylos Vessel GuardXylos Corporation · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082782Replication Medical Vessel GuardReplication Medical, Inc. · 2009 · cites it directly3descendants
- K103558Synthes Scout Vessel GuardSynthes Spine · 2011 · cites it directly1descendant
- K111048Synthes Scout Tack FixationSynthes Spine · 2012 · 2 generations on0descendants
- K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011 · cites it directly0descendants
- K100984Xylos Vessel GuardXylos Corporation · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811841 | Gore-Tex Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1981 | — |
| −1 | K984526 | Acuseal Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1999 | — |
| 0 (this device) | K061727 | Gore Preclude Vessel Guard | W. L. Gore & Associates, Inc. | 2006 | — |
| +1 | K082782 | Replication Medical Vessel Guard | Replication Medical, Inc. | 2009 | — |
| +1 | K103558 | Synthes Scout Vessel Guard | Synthes Spine | 2011 | — |
| +2 | K111048 | Synthes Scout Tack Fixation | Synthes Spine | 2012 | — |
| +1 | K101805 | Hydrofix Vaso Shield | Mimedx Group, Inc. | 2011 | — |
| +2 | K100984 | Xylos Vessel Guard | Xylos Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K984526 | Acuseal Cardiovascular PatchSummary page 2…510(k) Premarket Notification submission is to propose a new indication for the GORE ACUSEAL Cardiovascular Patch (previously cleared under K984526 April 8, 1999). This new indication (shown below) would be markcted under the name GORE PRECLUDE'C.… | 1999 |
What descends from it? (6)
4 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?
- The line of descent spans 25 years and passes through 1 company; a new generation was cleared every 17.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082782 (Replication Medical, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K984526.
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?
The Gore PRECLUDE® Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery to reduce the risk of potential vessel damage during a revision surgery by providing a plane of dissection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061727: Gore Preclude Vessel Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061727
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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