Cleared Special

K191138 - AeroForm Tissue Expander, Smooth

K191138 is an FDA 510(k) clearance for AeroForm Tissue Expander, manufactured by Airxpanders, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PQN cleared through the Special 510(k) pathway after a 72-day FDA review.

K191138 · Airxpanders, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
72d
Days
Class 2
Risk

K191138 is an FDA 510(k) clearance for the AeroForm Tissue Expander, Smooth. Classified as Carbon Dioxide Gas Controlled Tissue Expander (product code PQN), Class II - Special Controls.

Submitted by Airxpanders, Inc. (San Jose, US). The FDA issued a Cleared decision on July 11, 2019 after a review of 72 days - a notably fast clearance cycle.

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. 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 - K191138

510(k) Number K191138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2019
Decision Date July 11, 2019
Days to Decision 72 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

PQN Device Classification - Class 2, Special Controls

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.

K191138 · AeroForm Tissue Expander, Smooth
Download PDF FDA Summary Airxpanders, Inc.