Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Earflo, Inc.. It received FDA 510(k) clearance on 2026-02-10 under approval 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. It is manufactured by Earflo, Inc.. The 510(k) number is K252751.

When was Earflo (EF001) approved by the FDA?

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

What company makes Earflo (EF001)?

Earflo (EF001) is manufactured by Earflo, Inc..

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

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

Related Devices (Code: MJV)

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

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.

↑