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510(k) K253612

Acclarent AERA Eustachian Tube Balloon Dilation System by Acclarent, Inc. — Product Code PNZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2026
Date Received
November 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eustachian Tube Balloon Dilation Device
Device Class
Class II
Regulation Number
874.4180
Review Panel
EN
Submission Type

The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

Other clearances by Acclarent, Inc.

  • K230742 — ACCLARENT AERA Eustachian Tube Dilation System (December 13, 2023)
  • K231862 — TruDi® Navigation System V3 (FG-2000-00) (July 21, 2023)
  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K190532 — TruDi NAV Wire (May 3, 2019)
  • K183090 — Relieva Tract Balloon Dilation System (April 19, 2019)
  • K180948 — TruDi NAV Suction Instruments (July 20, 2018)

Other clearances for product code PNZ

  • K230742 — ACCLARENT AERA Eustachian Tube Dilation System (December 13, 2023)
  • K223542 — TubaVent Balloon Dilatation System (August 3, 2023)
  • K230065 — VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSur (May 26, 2023)
  • K220027 — Audion ET dilation system (April 12, 2022)
  • K210841 — NuVent Eustachian Tube Dilation Balloon (August 16, 2021)
  • K171761 — ACCLARENT AERA Eustachian Tube Balloon Dilation System (January 16, 2018)
  • K163509 — XprESS ENT Dilation System (April 5, 2017)
  • DEN150056 — Acclarent Aera Eustachian Tube Balloon Dilation System (September 16, 2016)