Cleared Special

K122105 - SMI CARDIOVASCULAR PATCH

K122105 is an FDA 510(k) clearance for SMI CARDIOVASCULAR PATCH, manufactured by Solinas Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Special 510(k) pathway after a 143-day FDA review.

K122105 · Solinas Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
143d
Days
Class 2
Risk

K122105 is an FDA 510(k) clearance for the SMI CARDIOVASCULAR PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Solinas Medical, Inc. (Sunny Vale, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 143 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K122105

510(k) Number K122105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date December 07, 2012
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Modification to existing cleared device.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 83
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K122105.
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K111187 · Cormatrix Cardiovascular, Inc. · Jul 2011
ALBOSURE POLYESTER VASCULAR PATCH
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K122105 · SMI CARDIOVASCULAR PATCH
Download PDF FDA Summary Solinas Medical, Inc.