# K252751: Earflo (EF001)

- Pathway: 510(k) (Traditional)
- Applicant: Earflo, Inc.
- Decided: Feb 10, 2026 after 165 days
- Product code: MJV (Device, Inflation, Middle Ear)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K920840 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230502: Ear Pressure Relief Device (Model:ER813B), Ningbo Albert Novosino Co., Ltd. (2023) Summary page 5.

## Indications for use
The Earflo is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Earflo provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

Source page: https://510kreport.com/device/K252751
Methodology: https://510kreport.com/methodology