# K111875: Relieva Spin Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Oct 11, 2011 after 102 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; 4 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 2.
- 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
- K120280: Relieva Seeker Balloon Sinuplasty System (2012), 2 descendants of its own
- K171687: Relieva SpinPlus Nav Balloon Sinuplasty System (2017), 1 descendant of its own
- K201115: Next Generation Balloon Dilation System (2020), 0 descendants of its own
- K153341: Relieva Scout Multi-Sinus Dilation System (2016), 0 descendants of its own

## Indications for use
The Relieva Spin Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K111875
Methodology: https://510kreport.com/methodology