510(k) Report

510(k) · Decided

Decided

Hydrofix Vaso Shield, Model HVS-001-0610

K101826510(k) SpecialDecided Jul 28, 201027-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 Jul 28, 2010 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 28, 2010
Review
27 days
Class
Class II
Product code
OMR
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K101826Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · OMR

1in 2012

2009: 32010: 32011: 32012: 1
2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMR

78in 2011

2009: 105 days median2010: 62 days median2011: 78 days median
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

2013: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
2009310500
201036200
201137800
20121—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Mimedx Group, Inc.

5 FDA decisions under this applicant name. See the company

  • K100313Hydrofix Surgical SheetMimedx Group, Inc. · 2011
  • K111137Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
  • K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
  • K100905Hydrofix Surgical SheetMimedx Group, Inc. · 2010

Recent decisions in OMR

The OMR category page

  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K111137Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
  • K101805Hydrofix Vaso ShieldMimedx Group, Inc. · 2011
  • K103558Synthes Scout Vessel GuardSynthes Spine · 2011
  • K100984Xylos Vessel GuardXylos Corporation · 2010

https://510kreport.com/device/K101826 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101826: Hydrofix Vaso Shield, Model HVS-001-0610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101826

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026