Cleared Traditional

K203754 - Eustachi Ear Pressure Relief Device (FDA 510(k) Clearance)

K203754 · Exercore, LLC · Ear, Nose, Throat device
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Feb 2021
Decision
58d
Days
-
Risk

K203754 is an FDA 510(k) clearance for the Eustachi Ear Pressure Relief Device. Classified as Device, Inflation, Middle Ear within the MJV classification (a niche ENT category for middle ear pressure regulation devices).

Submitted by Exercore, LLC (Shakopee, US). The FDA issued a Cleared decision on February 19, 2021 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. Middle ear inflation devices represent a low-volume ENT category with limited predicate history - the 165-day review reflects the FDA's careful equivalence assessment for this specialized device type.

View all Exercore, LLC devices

Submission Details

510(k) Number K203754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date February 19, 2021
Days to Decision 58 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 89d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJV Device, Inflation, Middle Ear
Device Class -

Regulatory Consultant

DuVal & Associates, P.A.
Lisa Pritchard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.