# K073276: Iontophoresis System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Mar 5, 2008 after 105 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: 1 generation back to K870272 (1987). 2 ancestors in all.
2 later devices descend 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)
- K884834: Xomed Ionesthetizer (TM), Xomed, Inc. (1989) Summary page 1.
- K870272: Model 6110C Otophor, Life-Tech Intl., Inc. (1987) Summary page 1.

## Most influential descendants
- K110636: Tula Iontophoresis System (2011), 1 descendant of its own
- K150453: TULA Iontophoresis System with Earset (2015), 0 descendants of its own

## Indications for use
The Iontophoresis System 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/K073276
Methodology: https://510kreport.com/methodology