510(k) · Decided
DecidedXylos Vessel Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xylos Corporation · OMR Vessel Guard Or Cover
Cleared on Jul 7, 2010 as substantially equivalent to K090778 (Xylos Corporation, 2009) and 3 other predicates after a 90-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Jul 7, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- OMR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K921895 (1992). 65 ancestors in all, the oldest K811841 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations between
- 3 generations backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- 2 generations backK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- 1 generation backK090778 Mta Protective SheetXylos Corporation · 2009
- This deviceK100984 Xylos Vessel GuardXylos Corporation · 2010
Show all 13 generations
- Root · 13 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 12 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 11 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 10 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 9 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 8 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 7 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 6 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 5 generations backK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006 · Recalled
- 4 generations backK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- 3 generations backK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- 2 generations backK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- 1 generation backK090778 Mta Protective SheetXylos Corporation · 2009
- This deviceK100984 Xylos Vessel GuardXylos Corporation · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −12 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −11 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −10 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −9 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −7 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −6 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −5 | K060989 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | 1 |
| −4 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| −3 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| −2 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| −1 | K090778 | Mta Protective Sheet | Xylos Corporation | 2009 | — |
| 0 (this device) | K100984 | Xylos Vessel Guard | Xylos Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (4)
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 |
|---|---|---|---|
| * | K090778 | Mta Protective SheetSummary page 1…Vessel Guard Regulatory Class: Class II Product Codes: OMR Predicate Device(s): MTA Tm Protective Sheet, K090778 Replication Medical Vessel Guard, K082782, and the predicates of… | 2009 |
| * | K082782 | Replication Medical Vessel GuardSummary page 1…Product Codes: OMR Predicate Device(s): MTA Tm Protective Sheet, K090778 Replication Medical Vessel Guard, K082782, and the predicates of Replication Medical Vessel Guard: PRE… | 2009 |
| * | K062161 | Gore Propaten Vascular GraftSummary page 1…ssel Guard, K082782, and the predicates of Replication Medical Vessel Guard: PRECLUDEO Vessel Guard, K062161 PRECLUDE® IMA Sleeve, K960532 Device Description: XYLOST Vessel Guard is a flexible, no… | 2006 |
| * | K960532 | Preclude Ima SleeveSummary page 1…Replication Medical Vessel Guard: PRECLUDEO Vessel Guard, K062161 PRECLUDE® IMA Sleeve, K960532 Device Description: XYLOST Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbial- derived cel… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 65 ancestors have a recall of any class.
- 1 other device also cites its predicate K090778.
How does its category compare?
All OMR devicesOMR Vessel Guard Or Cover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
XYLOS TM Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100984: Xylos Vessel Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100984
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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