# K170075: AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)

- Pathway: 510(k) (Traditional)
- Applicant: Airxpanders, Inc.
- Decided: Apr 3, 2017 after 84 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: 1 generation back to DEN150055 (2016). 1 ancestor in all.
1 later device descends 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)
- DEN150055: AeroForm Tissue Expander System, Airxpanders, Inc. (2016) Summary page 5.

## Most influential descendants
- 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® Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond 6 months.

Source page: https://510kreport.com/device/K170075
Methodology: https://510kreport.com/methodology