# K191138: AeroForm Tissue Expander, Smooth

- Pathway: 510(k) (Special)
- Applicant: Airxpanders, Inc.
- Decided: Jul 11, 2019 after 72 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
Longest line of descent: 2 generations back to DEN150055 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170075: AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5), Airxpanders, Inc. (2017) Summary page 4.

## Indications for use
The AeroForm® Tissue Expander System, Smooth 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® Tissue Expander, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months

Source page: https://510kreport.com/device/K191138
Methodology: https://510kreport.com/methodology