Cleared Traditional

K252751 - Earflo (EF001) (FDA 510(k) Clearance)

K252751 · Earflo, Inc. · Ear, Nose, Throat device
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Feb 2026
Decision
165d
Days
-
Risk

K252751 is an FDA 510(k) clearance for the Earflo (EF001). Classified as Device, Inflation, Middle Ear within the MJV classification (a niche ENT category for middle ear pressure regulation devices).

Submitted by Earflo, Inc. (San Carlos, US). The FDA issued a Cleared decision on February 10, 2026 after a review of 165 days - an extended review 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: Standard predicate-based submission. 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 Earflo, Inc. devices

Submission Details

510(k) Number K252751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2025
Decision Date February 10, 2026
Days to Decision 165 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
76d slower than avg
Panel avg: 89d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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