Not Cleared Direct

AeroForm Tissue Expander System (DEN150055) - FDA 510(k) Clearance

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

DEN150055 · Airxpanders, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
380d
Days
Class 2
Risk

DEN150055 is an FDA 510(k) submission (not cleared) for the AeroForm Tissue Expander System. Classified as Carbon Dioxide Gas Controlled Tissue Expander (product code PQN), Class II - Special Controls.

Submitted by Airxpanders, Inc. (Palo Alto, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2016 after a review of 380 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3510 - the FDA general and plastic surgery 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 380 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 Airxpanders, Inc. devices

Submission Details

510(k) Number DEN150055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 07, 2015
Decision Date December 21, 2016
Days to Decision 380 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 115d · This submission: 380d
Pathway characteristics

Device Classification

Product Code PQN Carbon Dioxide Gas Controlled Tissue Expander
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3510
Definition A Carbon Dioxide Gas Controlled Tissue Expander Is Intended For Tissue Expansion.
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 General & Plastic Surgery devices follow this clearance model.