# K132297: EM Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Nov 5, 2013 after 104 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). 80 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121351: Sinus Dilation System, Entrigue Surgical, Inc. (2012) Summary page 2.
- K102003: Xpress Balloon Device, Entellus Medical, Inc. (2010) Summary page 2.

## Most influential descendants
- K201472: VenSure Balloon Device, VenSure Nav Balloon Device (2020), 1 descendant of its own
- K161698: Relieva UltirraNav Sinus Balloon Catheter (2016), 1 descendant of its own
- K230065: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (2023), 0 descendants of its own
- K172737: MESIRE - Balloon Sinus Dilatation System (2017), 0 descendants of its own
- K152121: NuVent EM Sinus Dilation System (2015), 0 descendants of its own

## Indications for use
The EM Sinus Dilation System is intended for use in sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, and sphenoid sinuses. The EM Sinus Dilation system is used in conjunction with the Medtronic computer-assisted surgery system. The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Source page: https://510kreport.com/device/K132297
Methodology: https://510kreport.com/methodology