Earflo (EF001)— 510(k) K252751

Name: FDA 510(k) clearance K252751
Creator: U.S. Food and Drug Administration
Published: 2026-02-10

Substantially Equivalent

Earflo, Inc.

FDA 510(k) clearance K252751 for Earflo (EF001), Substantially Equivalent on 2026-02-10. Applicant: Earflo, Inc.. Device class: Unclassified.

Summary

Earflo's Earflo (EF001) is filed under product code MJV, middle ear inflation device. The record doesn't describe it beyond the name and that code name.

Class U, with no regulation number. The classification panel is listed as Unknown, and the Ear, Nose, Throat review panel handled it as a Traditional 510(k).

Earflo filed from San Carlos, California. Review took 165 calendar days (August 29, 2025 to February 10, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Earflo, Inc.
Product code: Product code MJV
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-08-29
Decision date: 2026-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.