# K230258: BB 8 Sinus Dilation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Excelent, Inc.
- Decided: May 25, 2023 after 114 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: 20 generations back to K936109 (1994). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 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.
- K152435: PassAssist LED Light Fiber, Entellus Medical, Inc. (2015) Summary page 4.

## 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/K230258
Methodology: https://510kreport.com/methodology