De Novo · Granted
GrantedAeroForm Tissue Expander System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airxpanders, Inc. · PQN Carbon Dioxide Gas Controlled Tissue Expander
Granted on Dec 21, 2016 as a new device type through De Novo after a 380-day review. 2 later devices descend from it.
- Decided
- Dec 21, 2016
- Review
- 380 days
- Class
- Class II
- Product code
- PQN
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN150055 AeroForm Tissue Expander SystemAirxpanders, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK170075 AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Airxpanders, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK191138 AeroForm Tissue Expander, SmoothAirxpanders, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150055 | AeroForm Tissue Expander System | Airxpanders, Inc. | 2016 | — |
| +1 | K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | Airxpanders, Inc. | 2017 | — |
| +2 | K191138 | AeroForm Tissue Expander, Smooth | Airxpanders, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170075 (Airxpanders, Inc., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PQN devicesPQN Carbon Dioxide Gas Controlled Tissue Expander: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PQN
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PQN
Too few PQN 510(k)s in any year since 2007 to give a median.
Recalls per year · PQN
No recall names PQN since 2007.
Adverse event reports per year · PQN
1in 2018
MAUDE reports naming product code PQN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150055 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150055: AeroForm Tissue Expander System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150055
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026