# DEN150055: AeroForm Tissue Expander System

- Pathway: De Novo (Direct)
- Applicant: Airxpanders, Inc.
- Decided: Dec 21, 2016 after 380 days
- Product code: PQN (Carbon Dioxide Gas Controlled Tissue Expander)
- Device class: 2
- Regulation: 21 CFR 878.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K170075: AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (2017), 1 descendant of its own
- K191138: AeroForm Tissue Expander, Smooth (2019), 0 descendants of its own

## Indications for use
The AeroForm Tissue Expander System is used for soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast. The AeroForm Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Source page: https://510kreport.com/device/DEN150055
Methodology: https://510kreport.com/methodology