# K230502: Ear Pressure Relief Device (Model:ER813B)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Albert Novosino Co., Ltd.
- Decided: Jun 9, 2023 after 105 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: 3 generations back to K920840 (1992). 4 ancestors in all.
1 later device descends 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)
- K203754: Eustachi Ear Pressure Relief Device, Exercore, LLC (2021) Summary page 5.

## Most influential descendants
- K252751: Earflo (EF001) (2026), 0 descendants of its own

## Indications for use
The Ear Pressure Relief Device 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 Ear Pressure Reliever 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/K230502
Methodology: https://510kreport.com/methodology