# K120280: Relieva Seeker Balloon Sinuplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Nov 5, 2012 after 280 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: 15 generations back to K936109 (1994). 82 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111875: Relieva Spin Sinus Dilation System, Acclarent, Inc. (2011) Summary page 1.
- K102003: Xpress Balloon Device, Entellus Medical, Inc. (2010) Summary page 1.
- K071845: Relieva Luma Sinus Illumination System, Model Sis-100A, Acclarent, Inc. (2007) Summary page 1.

## Most influential descendants
- K153341: Relieva Scout Multi-Sinus Dilation System (2016), 0 descendants of its own
- K140160: Relieva Scout Sinus Dilation System (2014), 0 descendants of its own

## Indications for use
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.

Source page: https://510kreport.com/device/K120280
Methodology: https://510kreport.com/methodology