# K111254: Relieva Solo Elite Sinus Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Aug 22, 2011 after 110 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: 14 generations back to K936109 (1994). 80 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073041: Relieva and Relieva Acella Sinus Balloon Catheter, Acclarent, Inc. (2008) Summary page 1.
- K102003: Xpress Balloon Device, Entellus Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K143541: Relieva SpinPlus Balloon Sinuplasty System (2015), 2 descendants of its own
- K171687: Relieva SpinPlus Nav Balloon Sinuplasty System (2017), 1 descendant of its own
- K161698: Relieva UltirraNav Sinus Balloon Catheter (2016), 1 descendant of its own
- K201115: Next Generation Balloon Dilation System (2020), 0 descendants of its own
- K190525: RELIEVA ULTIRRA Sinus Balloon Catheter (2019), 0 descendants of its own

## Indications for use
The Relieva Solo Elite Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the Relieva Solo Elite Sinus Balloon Catheter is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.

Source page: https://510kreport.com/device/K111254
Methodology: https://510kreport.com/methodology