# K160770: Vent-Os Sinus Dilation family

- Pathway: 510(k) (Traditional)
- Applicant: Sinusys Corporation
- Decided: Jun 29, 2016 after 100 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: 17 generations back to K936109 (1994). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121943: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2012) Summary page 4.

## Indications for use
SinuSys Vent-Os® Sinus Dilation family is intended to provide a means to access the sinus space and to dilate sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures. • The Vent-Os Maxillary Dilation System is indicated for dilation of Maxillary sinus and associated spaces. • The Vent-Os Frontal Dilation System is indicated for dilation of the Frontal recess and associated spaces. • The Vent-Os Sphenoid Dilation System is indicated for dilation of Sphenoid sinus and associated spaces.

Source page: https://510kreport.com/device/K160770
Methodology: https://510kreport.com/methodology