510(k) · Cleared
ClearedXprESS ENT Dilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entellus Medical, Inc. · PNZ Eustachian Tube Balloon Dilation Device
Cleared on Apr 5, 2017 as substantially equivalent to K152434 (Entellus Medical, Inc., 2015) and 1 other predicate after a 111-day review. Its family tree reaches back 20 generations to 1994. 9 later devices descend from it.
- Decided
- Apr 5, 2017
- Review
- 111 days
- Class
- Class II
- Product code
- PNZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K936109 (1994). 86 ancestors in all, the oldest K800617 (1980). 9 later devices descend from it, 5 citing it directly.
- Root · 20 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 16 generations between
- 3 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 2 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 1 generation backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- This deviceK163509 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
- Descendant · cites it directly · 0 of its ownK230065 VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation…Fiagon GmbH · 2023
Show all 20 generations
- Root · 20 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 19 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 18 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 17 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 16 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 15 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 14 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 13 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 12 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 11 generations backK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- 10 generations backK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 9 generations backK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- 8 generations backK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- 7 generations backK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- 6 generations backK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
- 5 generations backK121174 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 4 generations backK121943 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2012
- 3 generations backK132440 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2013
- 2 generations backK142252 XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2014
- 1 generation backK152434 XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc. · 2015
- This deviceK163509 XprESS ENT Dilation SystemEntellus Medical, Inc. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −19 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −18 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −17 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −16 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −15 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −14 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −13 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −12 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −11 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| −10 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −9 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| −8 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −7 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| −6 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
| −5 | K121174 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −4 | K121943 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2012 | — |
| −3 | K132440 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2013 | — |
| −2 | K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014 | — |
| −1 | K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015 | — |
| 0 (this device) | 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 | — |
| +1 | K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System… | Fiagon GmbH | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K152434 | XprESS Multi-Sinus Dilation SystemSummary page 4…PNZ Regulation Number: Class II, 21 CFR 874.4180 Predicate Devices: XprESS Multi-Sinus Dilation System [K152434] Aera Eustachian Tube Balloon Dilation System [DEN150056] Device Description: The X… | 2015 |
| * | DEN150056 | Acclarent Aera Eustachian Tube Balloon Dilation SystemSummary page 4…ices: XprESS Multi-Sinus Dilation System [K152434] Aera Eustachian Tube Balloon Dilation System [DEN150056] Device Description: The XprESS ENT Dilation System is intended to remodel or recreate the sinus outflow tract and dilate the Eus… | 2016 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation System | 2018 | 5 |
| K230065 | VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav… | 2023 | 0 |
| K220027 | Audion ET dilation system | 2022 | 0 |
| K210841 | NuVent Eustachian Tube Dilation Balloon | 2021 | 0 |
| K201398 | SINUSPRIME Dilation System | 2020 | 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?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 86 ancestors have a recall of any class.
- Of its descendants, K171761 (Acclarent, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K152434.
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. 2017, 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?
To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163509: XprESS ENT Dilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163509
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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