# K142252: XprESS Multi-Sinus Dilation Tool

- Pathway: 510(k) (Special)
- Applicant: Entellus Medical, Inc.
- Decided: Oct 17, 2014 after 64 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: 18 generations back to K936109 (1994). 83 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132440: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K152434: XprESS Multi-Sinus Dilation System (2015), 11 descendants of its own
- 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
- K201472: VenSure Balloon Device, VenSure Nav Balloon Device (2020), 1 descendant of its own

## Indications for use
To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults 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/K142252
Methodology: https://510kreport.com/methodology