Cleared Special

K200566 - ADAPT Tissue

K200566 is an FDA 510(k) clearance for ADAPT Tissue, manufactured by Admedus Regen Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code PSQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K200566 · Admedus Regen Pty, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
30d
Days
Class 2
Risk

K200566 is an FDA 510(k) clearance for the ADAPT Tissue. Classified as Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ), Class II - Special Controls.

Submitted by Admedus Regen Pty, Ltd. (Malaga, AU). The FDA issued a Cleared decision on April 3, 2020 after a review of 30 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 - K200566

510(k) Number K200566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2020
Decision Date April 03, 2020
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

PSQ Device Classification - Class 2, Special Controls

Product Code PSQ Intracardiac Patch Or Pledget, Biologically Derived
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.
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 - PSQ Intracardiac Patch Or Pledget, Biologically Derived

All 10
Devices cleared under the same product code (PSQ) and FDA review panel - the closest regulatory comparables to K200566.
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MatriStem UBM Pericardial Patch
K191734 · Acell, Inc. · Nov 2019
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K183635 · Cryolife, Inc. · Feb 2019
K200566 · ADAPT Tissue
Download PDF FDA Summary Admedus Regen Pty, Lt…