510(k) · Decided
DecidedParadis Vaso Shield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinemedica, LLC · OMR Vessel Guard Or Cover
Cleared on Apr 20, 2009 after a 105-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Apr 20, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- OMR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK090022 Paradis Vaso ShieldSpinemedica, LLC · 2009
- Descendant · cites it directly · 1 of its ownK103558 Synthes Scout Vessel GuardSynthes Spine · 2011
- Descendant · cites it directly · 1 of its ownK100905 Hydrofix Surgical SheetMimedx Group, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK111048 Synthes Scout Tack FixationSynthes Spine · 2012
- Descendant · cites it directly · 0 of its ownK111137 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK101805 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K103558Synthes Scout Vessel GuardSynthes Spine · 2011 · cites it directly1descendant
- K100905Hydrofix Surgical SheetMimedx Group, Inc. · 2010 · cites it directly1descendant
- K111048Synthes Scout Tack FixationSynthes Spine · 2012 · 2 generations on0descendants
- K111137Hydrofix Vaso ShieldMimedx Group, Inc. · 2011 · cites it directly0descendants
- K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090022 | Paradis Vaso Shield | Spinemedica, LLC | 2009 | — |
| +1 | K103558 | Synthes Scout Vessel Guard | Synthes Spine | 2011 | — |
| +1 | K100905 | Hydrofix Surgical Sheet | Mimedx Group, Inc. | 2010 | — |
| +2 | K111048 | Synthes Scout Tack Fixation | Synthes Spine | 2012 | — |
| +1 | K111137 | Hydrofix Vaso Shield | Mimedx Group, Inc. | 2011 | — |
| +1 | K101805 | Hydrofix Vaso Shield | Mimedx Group, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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?
- Of its descendants, K103558 (Synthes Spine, 2011) has gone furthest, with 1 descendant of its own.
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 Paradis 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/K090022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090022: Paradis Vaso Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090022
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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