Acclarent, Inc. · Class II · Cleared Feb 19, 2026
| K-number | K253612 |
| Device name | Acclarent AERA Eustachian Tube Balloon Dilation System |
| Applicant | Acclarent, Inc. |
| Product code | PNZ |
| Device class | Class II |
| Decision date | Feb 19, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 874.4180 |
The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is a medical device used to mechanically dilate the Eustachian tube to treat persistent Eustachian tube dysfunction. For adults 18+, it is used for general Eustachian tube dilation; for children ages 8-17 with chronic otitis media with effusion refractory to prior surgery, it may be used alone or with adjunctive procedures.
The device includes a 6x16mm flexible balloon catheter with integrated dual-lumen shaft, nylon balloon, and a ball-tipped distal end (blueberry tip) designed to prevent advancement into the bony isthmus. It incorporates an endoscopic marker for positioning and is used with an inflation device. The technological characteristics are identical to the predicate device cleared in K230742.
The document cites compliance with ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action) as part of Quality Management System Regulation requirements. Specific consensus standards such as ISO, IEC, or ASTM test methods are not explicitly detailed in the performance data section.
Substantial equivalence is established because the ACCLARENT AERA® device has identical indications for use, labeling, and technological characteristics as the predicate device (K230742). Previously submitted bench testing, biocompatibility, sterilization, and stability data were leveraged. Additionally, validation testing confirmed that a 3D-printed head model meets the special control requirement for simulated use training as an alternative to cadaver training.
View the full FDA submission: accessdata.fda.gov