510(k) · Cleared
ClearedAeroForm Tissue Expander, Smooth
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
Cleared on Jul 11, 2019 as substantially equivalent to K170075 (Airxpanders, Inc., 2017) after a 72-day review. Its family tree reaches back 2 generations to 2016.
- Decided
- Jul 11, 2019
- Review
- 72 days
- Class
- Class II
- Product code
- PQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150055 (2016). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Summary page 4…umber Clearance Date AeroForm® Tissue Expander System AirXpanders, Inc. K170075 04/03/2017 REFERENCE DEVICES There are other tissue expanders with a smooth shell construction that have been cleared as… | 2017 |
| † | K182054 | Natrelle 133S Tissue Expander | 2018 |
| † | K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
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. 2019, 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, 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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191138: AeroForm Tissue Expander, Smooth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191138
Report an extraction error
Are you the manufacturer?
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