# K163509: XprESS ENT Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Apr 5, 2017 after 111 days
- Product code: PNZ (Eustachian Tube Balloon Dilation Device)
- Device class: 2
- Regulation: 21 CFR 874.4180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K936109 (1994). 86 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152434: XprESS Multi-Sinus Dilation System, Entellus Medical, Inc. (2015) Summary page 4.
- DEN150056: Acclarent Aera Eustachian Tube Balloon Dilation System, Acclarent, Inc. (2016) Summary page 4.

## Most influential descendants
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System (2018), 5 descendants of its own
- K230742: ACCLARENT AERA Eustachian Tube Dilation System (2023), 1 descendant of its own
- K253612: Acclarent AERA Eustachian Tube Balloon Dilation System (2026), 0 descendants of its own
- K223542: TubaVent Balloon Dilatation System (2023), 0 descendants of its own
- K230065: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K163509
Methodology: https://510kreport.com/methodology