# K133016: Vent-OS Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Sinusys Corporation
- Decided: Dec 9, 2013 after 75 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). 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)
- K111875: Relieva Spin Sinus Dilation System, Acclarent, Inc. (2011)
- K121943: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2012) Summary page 1.
- K121351: Sinus Dilation System, Entrigue Surgical, Inc. (2012) Summary page 1.

## Indications for use
The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K133016
Methodology: https://510kreport.com/methodology