510(k) · Cleared
ClearedAcclarent 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
Cleared on Feb 19, 2026 as substantially equivalent to K230742 (Acclarent, Inc., 2023) after a 93-day review. Its family tree reaches back 23 generations to 1994.
- Decided
- Feb 19, 2026
- Review
- 93 days
- Class
- Class II
- Product code
- PNZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K936109 (1994). 89 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 23 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 19 generations between
- 3 generations backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- 2 generations backK171761 ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2018
- 1 generation backK230742 ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. · 2023
- This deviceK253612 Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2026
Show all 23 generations
- Root · 23 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 22 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 21 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 20 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 19 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 18 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 17 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 16 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 15 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 14 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 13 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 12 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 11 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 10 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 9 generations backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 8 generations backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 7 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 6 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 5 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 4 generations backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- 3 generations backK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
- 2 generations backK171761 ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2018
- 1 generation backK230742 ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. · 2023
- This deviceK253612 Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −22 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −21 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −20 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −19 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −18 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −17 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −16 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −15 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −14 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −13 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −12 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −11 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −10 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −9 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −8 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −7 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −6 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
| −5 | K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014 | — |
| −4 | K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015 | — |
| −3 | K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | 2017 | — |
| −2 | K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2018 | — |
| −1 | K230742 | ACCLARENT AERA Eustachian Tube Dilation System | Acclarent, Inc. | 2023 | — |
| 0 (this device) | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 12 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 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 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 K230742 ACCLARENT AERA Eustachian Tube Dilation Systemscore 15.8 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemSummary page 5…tion Name: Eustachian Tube Balloon Dilation System Product Code: PNZ Predicate Devices: ACCLARENT AERA® Eustachian Tube Balloon Dilation System (K230742) Device Description: The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includ… | 2023 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 89 ancestors have a recall of any class.
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. 2026, 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?
The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older.
For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253612: Acclarent AERA Eustachian Tube Balloon Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253612
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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