Cleared Traditional

K162506 - PhotoFix Decellularized Bovine Pericardium

K162506 is an FDA 510(k) clearance for PhotoFix Decellularized Bovine Pericardium, manufactured by Cryolife, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K162506 · Cryolife, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
182d
Days
Class 2
Risk

K162506 is an FDA 510(k) clearance for the PhotoFix Decellularized Bovine Pericardium. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryolife, Inc. devices

FDA 510(k) Submission Details - K162506

510(k) Number K162506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date March 09, 2017
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 71
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K162506.
PeriBeam® Pericardial Membrane
K240775 · Tamabio · Apr 2025
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · Vascutek, Ltd. · Jul 2020
VascuCel
K162579 · Admedus Regen Pty, Ltd. · Oct 2016
CorMatrix Tyke
K152127 · Cormatrix Cardiovascular, Inc. · Feb 2016
PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
K142447 · Synovis Life Technologies, Inc. · Jan 2015