510(k) · Cleared
ClearedAeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
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 Apr 3, 2017 as substantially equivalent to DEN150055 (Airxpanders, Inc., 2016) after an 84-day review. Its family tree reaches back 1 generation to 2016. 1 later device descends from it.
- Decided
- Apr 3, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- PQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150055 (2016). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN150055 AeroForm Tissue Expander SystemAirxpanders, Inc. · 2016
- This deviceK170075 AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Airxpanders, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK191138 AeroForm Tissue Expander, SmoothAirxpanders, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K191138AeroForm Tissue Expander, SmoothAirxpanders, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150055 | AeroForm Tissue Expander System | Airxpanders, Inc. | 2016 | — |
| 0 (this device) | K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | Airxpanders, Inc. | 2017 | — |
| +1 | K191138 | AeroForm Tissue Expander, Smooth | Airxpanders, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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 |
|---|---|---|---|
| * | DEN150055 | AeroForm Tissue Expander SystemSummary page 5…bmission is: Trade Name Submitter DeNovo Number AeroForm® Tissue Expander System AirXpanders, Inc. DEN 150055 The predicate device has not been subjected to a design-related recall. DEVICE DESCRIPTION The AeroForm Tissue Expander System… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191138 | AeroForm Tissue Expander, Smooth | 2019 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K191138 (Airxpanders, Inc., 2019) has gone furthest, with 0 descendants 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. 2017, 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® Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not
intended for use beyond 6 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/K170075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170075: AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170075
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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