# K203754: Eustachi Ear Pressure Relief Device

- Pathway: 510(k) (Traditional)
- Applicant: Exercore, LLC
- Decided: Feb 19, 2021 after 58 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: 2 generations back to K920840 (1992). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073401: Earpopper, Model EP-2000, EP-2100, EP-3000, Micromedics, Inc. (2008) Summary page 4.

## Most influential descendants
- K230502: Ear Pressure Relief Device (Model:ER813B) (2023), 1 descendant of its own
- K252751: Earflo (EF001) (2026), 0 descendants of its own

## Indications for use
The Eustachi 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 Eustachi 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/K203754
Methodology: https://510kreport.com/methodology