Not Cleared Direct

DEN230087 - AMStent® Tracheobronchial Covered Stent System (FDA 510(k) Clearance)

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

DEN230087 · Peytant Solutions, Inc. · Anesthesiology device
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Oct 2024
Decision
301d
Days
Class 2
Risk

DEN230087 is an FDA 510(k) submission (not cleared) for the AMStent® Tracheobronchial Covered Stent System. Classified as Tracheal Prosthesis With Cover Material Derived From Human Sources (product code SDB), Class II - Special Controls.

Submitted by Peytant Solutions, Inc. (Plymouth, US). The FDA issued a Not Cleared (DENG) decision on October 16, 2024 after a review of 301 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.3721 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 301 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Peytant Solutions, Inc. devices

Submission Details

510(k) Number DEN230087 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 20, 2023
Decision Date October 16, 2024
Days to Decision 301 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 139d · This submission: 301d
Pathway characteristics

Device Classification

Product Code SDB Tracheal Prosthesis With Cover Material Derived From Human Sources
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.3721
Definition The Tracheal Prosthesis With Cover Material Derived From Human Sources Is An Expandable Tubular Device Made Of A Metal Material Covered With A Human-sourced Decellularized Material. It Is Intended To Be Implanted To Restore The Structure And/or Function Of The Trachea Or Tracheobronchial Tree. This Device May Also Include A Device Delivery System. This Device Type Does Not Include Products That Are Intended To Promote Regeneration, Impede Inflammatory Cascades, And Release Growth Factors.
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 Anesthesiology devices follow this clearance model.