Device class
Class II
Regulation 874.4180
Total clearances
6
2021-08-16 → 2026-02-19
Definition
What is Eustachian Tube Balloon Dilation Device
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.4180
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 69705 |
CPT
|
— |
High
|
Nasopharynx, endoscopic examination; diagnostic |
| 92004 |
CPT
|
— |
Medium
|
Comprehensive eye exam with medical decision making |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-02-19 |
K253612 |
Acclarent, Inc.
|
Acclarent AERA Eustachian Tube Balloon Dilation System |
| 2023-12-13 |
K230742 |
Acclarent, Inc.
|
ACCLARENT AERA Eustachian Tube Dilation System |
| 2023-08-03 |
K223542 |
Spiggle & Theis Medizintechnik GmbH
|
TubaVent Balloon Dilatation System |
| 2023-05-26 |
K230065 |
Fiagon GmbH
|
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System |
| 2022-04-12 |
K220027 |
Entellus Medical, Inc.
|
Audion ET dilation system |
| 2021-08-16 |
K210841 |
Medtronic Xomed, Inc.
|
NuVent Eustachian Tube Dilation Balloon |