De Novo · Granted
GrantedAcclarent Aera Eustachian Tube Balloon Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · PNZ Eustachian Tube Balloon Dilation Device
Granted on Sep 16, 2016 as a new device type through De Novo after a 284-day review. 10 later devices descend from it.
- Decided
- Sep 16, 2016
- Review
- 284 days
- Class
- Class II
- Product code
- PNZ
- Recalls
- None
10 later devices descend from it, 2 citing it directly.
- This deviceDEN150056 Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK171761 ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK230742 ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK253612 Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK223542 TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K163509XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017 · cites it directly9descendants
- K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2018 · cites it directly5descendants
- K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. · 2023 · 2 generations on1descendant
- K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2026 · 3 generations on0descendants
- K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2016 | — |
| +1 | K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017 | — |
| +1 | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2018 | — |
| +2 | K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | 2023 | — |
| +3 | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2026 | — |
| +2 | K223542 | TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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 PNZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PNZ device
- #1 K253612 Acclarent AERA Eustachian Tube Balloon…score 17.5 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K163509 (Entellus Medical, Inc., 2017) has gone furthest, with 9 descendants of its own.
How does its category compare?
All PNZ devicesPNZ Eustachian Tube Balloon Dilation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PNZ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PNZ
251in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNZ
No recall names PNZ since 2007.
Adverse event reports per year · PNZ
3in 2025
MAUDE reports naming product code PNZ, 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 | 4 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 251 | 0 | 4 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
indicated to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 22 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150056 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150056: Acclarent Aera Eustachian Tube Balloon Dilation System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150056
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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