# K150453: TULA Iontophoresis System with Earset

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: May 20, 2015 after 89 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- 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 K870272 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110636: Tula Iontophoresis System, Acclarent, Inc. (2011) Summary page 5.

## Indications for use
The Iontophoresis System with Earset is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.

Source page: https://510kreport.com/device/K150453
Methodology: https://510kreport.com/methodology