Cleared Traditional

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (K170075) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170075 · Airxpanders, Inc. · General & Plastic Surgery device
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Apr 2017
Decision
84d
Days
Class 2
Risk

K170075 is an FDA 510(k) clearance for the AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5). 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 Cleared decision on April 3, 2017 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Airxpanders, Inc. devices

Submission Details

510(k) Number K170075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2017
Decision Date April 03, 2017
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.