510(k) · Decided
DecidedHydrofix Vaso Shield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mimedx Group, Inc. · OMR Vessel Guard Or Cover
Cleared on Apr 8, 2011 as substantially equivalent to K090022 (Spinemedica, LLC, 2009) and 3 other predicates after a 284-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Apr 8, 2011
- Review
- 284 days
- Class
- Class II
- Product code
- OMR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K811841 (1981). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK101805 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
View 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) | K101805 | Hydrofix Vaso Shield | Mimedx Group, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K090022 | Paradis Vaso ShieldSummary page 1…over for vessels during anterior vertebral surgery. Substantially Equivalent Devices: The following devices as substantially equivalent predicate devices listed below. K090022 ParadisVaso ShieldTM K093551 Paradis Vaso ShieldTM K 100905 HydroFixTM Vaso Shield K061727 Gore PRECLUDE® Vessel… | 2009 |
| * | K093551 | Paradis Vaso ShieldSummary page 1…ior vertebral surgery. Substantially Equivalent Devices: The following devices as substantially equivalent predicate devices listed below. K090022 ParadisVaso ShieldTM K093551 Paradis Vaso ShieldTM K 100905 HydroFixTM Vaso Shield K061727 Gore PRECLUDE® Vessel Guard The MiMedx HydroFixT M… | 2009 |
| * | K100905 | Hydrofix Surgical SheetSummary page 2…ent Devices: The following devices as substantially equivalent predicate devices listed below. K090022 ParadisVaso ShieldTM K093551 Paradis Vaso ShieldTM K 100905 HydroFixTM Vaso Shield K061727 Gore PRECLUDE® Vessel Guard The MiMedx HydroFixT M Vaso Shield was shown to be substantially equiv… | 2010 |
| * | K061727 | Gore Preclude Vessel GuardSummary page 2…es as substantially equivalent predicate devices listed below. K090022 ParadisVaso ShieldTM K093551 Paradis Vaso ShieldTM K 100905 HydroFixTM Vaso Shield K061727 Gore PRECLUDE® Vessel Guard The MiMedx HydroFixT M Vaso Shield was shown to be substantially equivalent to previously cleared dev… | 2006 |
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 30 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K090022.
How does its category compare?
All OMR devicesOMR Vessel Guard Or Cover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 HydroFix Vaso ShieldTM is indicated for use as a cover for vessels following anterior vertebral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101805: Hydrofix Vaso Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101805
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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