Acclarent AERA Eustachian Tube Balloon Dilation System— 510(k) K253612
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K253612 for Acclarent AERA Eustachian Tube Balloon Dilation System, Substantially Equivalent on 2026-02-19. Applicant: Acclarent, Inc.. Device class: 2.
Summary
Acclarent's Acclarent AERA Eustachian Tube Balloon Dilation System is filed under product code PNZ, Eustachian tube balloon dilation device. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 874.4180. Ear, Nose, Throat is both the classification panel and the review panel. It came in as a Traditional 510(k).
Acclarent filed from Irvine, California. Review took 93 calendar days (November 18, 2025 to February 19, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Product code PNZ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code PNZ
view all- K230742 — ACCLARENT AERA Eustachian Tube Dilation System
- K223542 — TubaVent Balloon Dilatation System
- K230065 — VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
- K220027 — Audion ET dilation system
- K210841 — NuVent Eustachian Tube Dilation Balloon
More clearances from Acclarent, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.