# K201115: Next Generation Balloon Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Aug 27, 2020 after 122 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: 22 generations back to K936109 (1994). 111 ancestors in all.
No later device cites it as a predicate yet.
3 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171761: ACCLARENT AERA Eustachian Tube Balloon Dilation System, Acclarent, Inc. (2018) Summary page 4.
- K171687: Relieva SpinPlus Nav Balloon Sinuplasty System, Acclarent, Inc. (2017) Summary page 4.
- K143541: Relieva SpinPlus Balloon Sinuplasty System, Acclarent, Inc. (2015) Summary page 4.

## Indications for use
The NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; irrigate from within a target sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the NGB Balloon Dilation System is intended to provide a means to access the sinus space within and across nasal and sinus structures; dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures; irrigate from within the maxillary sinus; suction throughout therapeutic procedures and to facilitate diagnostic procedures. The NGB Balloon Dilation System is intended to dilate the cartilaginous Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older. The NGB Balloon Dilation System with the navigation guidewire may be utilized in conjunction with the TruDi™ Navigation System, to help direct access to nasal and paranasal spaces, and to confirm placement in the targeted anatomy. NGB may be utilized in conjunction with the TruDi™ NAV Wire to confirm placement of the balloon in the Eustachian tube. The NGB Balloon Dilation System with the illumination guidewire may be utilized to illuminate within and provide transcutaneous illumination across nasal and sinus structures.

Source page: https://510kreport.com/device/K201115
Methodology: https://510kreport.com/methodology