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FDA 510(k)

Earflo (EF001)

K-Number: K252751 · 2026-02-10

ApplicantEarflo, Inc.
Decision Date2026-02-10
Product CodeMJV
DecisionSubstantially Equivalent

Device Summary

Earflo (EF001) is the device name listed in this FDA 510(k) record. The listed applicant is Earflo, Inc.. It received FDA 510(k) clearance on 2026-02-10 under 510(k) number K252751. The device is classified under product code MJV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Earflo (EF001)?

Earflo (EF001) is a medical device that received FDA 510(k) clearance on 2026-02-10. The listed applicant is Earflo, Inc.. The 510(k) number is K252751.

When did Earflo (EF001) receive FDA 510(k) clearance?

Earflo (EF001) received FDA 510(k) clearance on 2026-02-10, under 510(k) number K252751.

Who is the listed applicant for Earflo (EF001)?

The FDA 510(k) record lists Earflo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Earflo (EF001)?

The FDA product code for Earflo (EF001) is MJV.

Related Devices (Code: MJV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230502Ear Pressure Relief Device(Model:ER813B)Ningbo Albert Novosino Co., Ltd.K203754Eustachi Ear Pressure Relief DeviceExercore, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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