# K102003: Xpress Balloon Device

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Oct 22, 2010 after 99 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: 13 generations back to K936109 (1994). 78 ancestors in all.
36 later devices descend from it; 7 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093007: Entellus Medical Balloon Device, Entellus Medical, Inc. (2010) Summary page 1.
- K081542: Modification to Entellus Medical RS-Series System, Entellus Medical, Inc. (2008)

## Most influential descendants
- K112506: Xpress Multi-Sinus Dilation Tool (2011), 21 descendants of its own
- K121174: Xpress Multi-Sinus Dilation Tool (2012), 20 descendants of its own
- K121943: Xpress Multi-Sinus Dilation Tool (2012), 17 descendants of its own
- K132440: Xpress Multi-Sinus Dilation Tool (2013), 14 descendants of its own
- K142252: XprESS Multi-Sinus Dilation Tool (2014), 13 descendants of its own

## Indications for use
To access and treat 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/K102003
Methodology: https://510kreport.com/methodology