# K152434: XprESS Multi-Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Nov 20, 2015 after 85 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K936109 (1994). 84 ancestors in all.
11 later devices descend from it; 2 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)
- K142252: XprESS Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K163509: XprESS ENT Dilation System (2017), 9 descendants of its own
- 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

## 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 trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Source page: https://510kreport.com/device/K152434
Methodology: https://510kreport.com/methodology