510(k) · Decided
DecidedReplication Medical Vessel Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Replication Medical, Inc. · OMR Vessel Guard Or Cover
Cleared on Apr 2, 2009 as substantially equivalent to K061727 (W. L. Gore & Associates, Inc., 2006) and 1 other predicate after a 192-day review. Its family tree reaches back 3 generations to 1981. 3 later devices descend from it.
- Decided
- Apr 2, 2009
- Review
- 192 days
- Class
- Class II
- Product code
- OMR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K811841 (1981). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK811841 Gore-Tex Cardiovascular PatchW. L. Gore & Associates, Inc. · 1981
- 2 generations backK984526 Acuseal Cardiovascular PatchW. L. Gore & Associates, Inc. · 1999
- 1 generation backK061727 Gore Preclude Vessel GuardW. L. Gore & Associates, Inc. · 2006
- This deviceK082782 Replication Medical Vessel GuardReplication Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK103558 Synthes Scout Vessel GuardSynthes Spine · 2011
- Descendant · cites it directly · 0 of its ownK111048 Synthes Scout Tack FixationSynthes Spine · 2012
- Descendant · cites it directly · 0 of its ownK100984 Xylos Vessel GuardXylos Corporation · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811841 | Gore-Tex Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1981 | — |
| −2 | K984526 | Acuseal Cardiovascular Patch | W. L. Gore & Associates, Inc. | 1999 | — |
| −1 | K061727 | Gore Preclude Vessel Guard | W. L. Gore & Associates, Inc. | 2006 | — |
| 0 (this device) | K082782 | Replication Medical Vessel Guard | Replication Medical, Inc. | 2009 | — |
| +1 | K103558 | Synthes Scout Vessel Guard | Synthes Spine | 2011 | — |
| +1 | K111048 | Synthes Scout Tack Fixation | Synthes Spine | 2012 | — |
| +1 | 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 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 OMR? 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? (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 |
|---|---|---|---|
| * | K061727 | Gore Preclude Vessel GuardSummary page 1…Clearance Date PRECLUDE Vessel Guard W.L. Gore & Associates, Inc K061727 8/7/2006 PRECLUDE IMA Sleeve W.L. Gore & Associates, Inc K960532 5/23/1996 The safety and effectiv… | 2006 |
| * | K960532 | Preclude Ima SleeveSummary page 1…Date PRECLUDE Vessel Guard W.L. Gore & Associates, Inc K061727 8/7/2006 PRECLUDE IMA Sleeve W.L. Gore & Associates, Inc K960532 5/23/1996 The safety and effectiveness of Vessel Guard is based upon the determination of the substantial equivalence as we… | 1996 |
What descends from it? (3)
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?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K103558 (Synthes Spine, 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K061727.
How does its category compare?
All OMR devicesOMR Vessel Guard Or Cover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMR
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OMR
78in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMR
No recall names OMR since 2007.
Adverse event reports per year · OMR
1in 2013
MAUDE reports naming product code OMR, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 3 | 105 | 0 | 0 |
| 2010 | 3 | 62 | 0 | 0 |
| 2011 | 3 | 78 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 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 EnGuardTM Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082782 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082782: Replication Medical Vessel Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082782
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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