WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253612

510(k) cleared

Acclarent AERA Eustachian Tube Balloon Dilation System

Acclarent, Inc. · Feb 19, 2026 · K253612

FDA cleared the Acclarent AERA Eustachian Tube Balloon Dilation System from Acclarent, Inc. on Feb 19, 2026 under K253612, a traditional 510(k). The device falls under product code PNZ, Eustachian Tube Balloon Dilation Device, regulated at 21 CFR 874.4180 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Nov 18, 2025. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Acclarent, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253612?

K253612 is the FDA 510(k) for Acclarent AERA Eustachian Tube Balloon Dilation System, submitted by Acclarent, Inc.. FDA's decision date was Feb 19, 2026, under product code PNZ (Eustachian Tube Balloon Dilation Device).

Who makes the Acclarent AERA Eustachian Tube Balloon Dilation System?

Acclarent, Inc., based in Irvine, CA, is the applicant of record for K253612.

How long did the K253612 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Feb 19, 2026, 93 days later.

← All decisions in February 2026