# K140160: Relieva Scout Sinus Dilation System

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Feb 20, 2014 after 29 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). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 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 1.

## Indications for use
For patients aged 18 and older, the Relieva Scout Sinus Dilation 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/K140160
Methodology: https://510kreport.com/methodology