Cleared Special

ADAPT Tissue (K200566) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200566 · Admedus Regen Pty, Ltd. · Cardiovascular device
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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.

View all Admedus Regen Pty, Ltd. devices

Submission Details

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.

Device Classification

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
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