# K153341: Relieva Scout Multi-Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Feb 12, 2016 after 85 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: 16 generations back to K936109 (1994). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120280: Relieva Seeker Balloon Sinuplasty System, Acclarent, Inc. (2012) Summary page 4.
- K121174: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2012) Summary page 4.
- K111875: Relieva Spin Sinus Dilation System, Acclarent, Inc. (2011) Summary page 4.

## Indications for use
For patients aged 18 and older, the Relieva Scout™ Multi-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 sphenoid, frontal, and maxillary sinus cavities 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/K153341
Methodology: https://510kreport.com/methodology