# K110636: Tula Iontophoresis System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Jun 16, 2011 after 104 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: 2 generations back to K870272 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073276: Iontophoresis System, Acclarent, Inc. (2008) Summary page 1.

## Most influential descendants
- K150453: TULA Iontophoresis System with Earset (2015), 0 descendants of its own

## Indications for use
The Iontophoresis System with Headset 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/K110636
Methodology: https://510kreport.com/methodology