Cleared Special

K111137 - HYDROFIX VASO SHIELD

K111137 is an FDA 510(k) clearance for HYDROFIX VASO SHIELD, manufactured by Mimedx Group, Inc.. The device is a Class 2 Cardiovascular device with product code OMR cleared through the Special 510(k) pathway after a 28-day FDA review.

K111137 · Mimedx Group, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
28d
Days
Class 2
Risk

K111137 is an FDA 510(k) clearance for the HYDROFIX VASO SHIELD. Classified as Vessel Guard Or Cover (product code OMR), Class II - Special Controls.

Submitted by Mimedx Group, Inc. (Marietta, US). The FDA issued a Cleared decision on May 20, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111137

510(k) Number K111137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 22, 2011
Decision Date May 20, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

OMR Device Classification - Class 2, Special Controls

Product Code OMR Vessel Guard Or Cover
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition These Device Types Do Not Include Devices Whose Primary Purpose Is To Minimize The Incidence Or Severity Of Adhesion Formation As A Result Of Vascular Surgery. Intended To Protect Vessels From Injury During Surgery (not To Be Confused With Wraps, Patches Or Covers Intended To Facilitate Revision Surgeries). Indicated To Wrap, Patch, Or Cover Intended To Cover Blood Vessels.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OMR Vessel Guard Or Cover

All 9
Devices cleared under the same product code (OMR) and FDA review panel - the closest regulatory comparables to K111137.
SYNTHES SCOUT TACK FIXATION
K111048 · Synthes Spine · Jun 2012
HYDROFIX VASO SHIELD
K101805 · Mimedx Group, Inc. · Apr 2011
SYNTHES SCOUT VESSEL GUARD
K103558 · Synthes Spine · Feb 2011
HYDROFIX VASO SHIELD, MODEL HVS-001-0610
K101826 · Mimedx Group, Inc. · Jul 2010
XYLOS VESSEL GUARD
K100984 · Xylos Corporation · Jul 2010
HYDROFIX SURGICAL SHEET
K100905 · Mimedx Group, Inc. · Jun 2010
K111137 · HYDROFIX VASO SHIELD
Download PDF FDA Summary Mimedx Group, Inc.