510(k) K252751
K252751 is an FDA 510(k) premarket notification submitted by Earflo, Inc. for the device "Earflo (EF001)". The FDA issued a decision of Substantially Equivalent on February 10, 2026. The device falls under product code MJV (Device, Inflation, Middle Ear), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2026
- Date Received
- August 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Inflation, Middle Ear
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type