# K121943: Xpress Multi-Sinus Dilation Tool

- Pathway: 510(k) (Special)
- Applicant: Entellus Medical, Inc.
- Decided: Aug 22, 2012 after 50 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: 16 generations back to K936109 (1994). 81 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121174: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K132440: Xpress Multi-Sinus Dilation Tool (2013), 14 descendants of its own
- K142252: XprESS Multi-Sinus Dilation Tool (2014), 13 descendants of its own
- 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

## 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/K121943
Methodology: https://510kreport.com/methodology