510(k) · Decided

Decided

Hydrofix Vaso Shield

K111137510(k) SpecialDecided May 20, 201128-day reviewClass II21 CFR 870.3470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mimedx Group, Inc. · OMR Vessel Guard Or Cover

Cleared on May 20, 2011 as substantially equivalent to K090022 (Spinemedica, LLC, 2009) after a 28-day review. Its family tree reaches back 1 generation to 2009.

Decided: May 20, 2011
Review: 28 days
Class: Class II
Product code: OMR
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K090022 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK090022 Paradis Vaso ShieldSpinemedica, LLC · 2009
This deviceK111137 Hydrofix Vaso ShieldMimedx Group, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090022	Paradis Vaso Shield	Spinemedica, LLC	2009	—
0 (this device)	K111137	Hydrofix Vaso Shield	Mimedx Group, Inc.	2011	—

FIG. 1 — Lineage of K111137, 2009–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K090022	Paradis Vaso Shield Summary page 2 …7 Substantially Equivalent Devices: The following devices as substantially equivalent predicate devices listed below. K090022 ParadisVaso ShieldTM K] 00905 HydroFixTM Vaso Shield KJ0l826HydroFixTM Vaso Shield KIO01805 HydroFixTM Vaso Shield The MiMedx IHy…	Spinemedica, LLC	2009	—
Kept off the family tree	K100905	FDA’s K100905 is Hydrofix Surgical Sheet Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Mimedx Group, Inc.	2010	—
Kept off the family tree	K101826	FDA’s K101826 is Hydrofix Vaso Shield, Model HVS-001-0610 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Mimedx Group, Inc.	2010	—
Kept off the family tree	K1001805	HydroFix Vaso Shield Number could not be read

Also cleared against K090022: 3 other devices →

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?

Its one ancestor has no recall.
3 other devices also cite its predicate K090022.

How does its category compare?

All OMR devices

OMR 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

2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMR

78in 2011

2007high 105 (2009) · low 62 (2010)2026

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

2007high 1 (2013) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	3	105	0
2010	3	62	0
2011	3	78	0
2012	1	—	0
2013	0	—	1
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The MiMedx Group, Inc. HydroFixTM Vaso Shield is indicated for use as a cover for vessels during anterior vertebral surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111137: 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/K111137

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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