510(k) · Cleared
ClearedIontophoresis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Mar 5, 2008 as substantially equivalent to K884834 (Xomed, Inc., 1989) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Mar 5, 2008
- Review
- 105 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870272 (1987). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK870272 Model 6110C OtophorLife-Tech Intl., Inc. · 1987
- This deviceK073276 Iontophoresis SystemAcclarent, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK110636 Tula Iontophoresis SystemAcclarent, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK150453 TULA Iontophoresis System with EarsetAcclarent, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870272 | Model 6110C Otophor | Life-Tech Intl., Inc. | 1987 | — |
| 0 (this device) | K073276 | Iontophoresis System | Acclarent, Inc. | 2008 | — |
| +1 | K110636 | Tula Iontophoresis System | Acclarent, Inc. | 2011 | — |
| +2 | K150453 | TULA Iontophoresis System with Earset | Acclarent, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EGJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EGJ device
- #1 K242041 STOPWET iontophoresis apparatus (SW01)score 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K884834 | Xomed Ionesthetizer (TM)Summary page 1…Number: 21 CIFR 890.5525 Classification Name: Device, Jontophoresis, Specific Uses Product Code: EGJ Predicate Devices: I. Lonesthetizer (K884834) manufactured by Xomed 2. Model 61 l OC Otophor (K870272) manufactured by Life-Tech. Device Descriptio… | 1989 |
| * | K870272 | Model 6110C OtophorSummary page 1…pecific Uses Product Code: EGJ Predicate Devices: I. Lonesthetizer (K884834) manufactured by Xomed 2. Model 61 l OC Otophor (K870272) manufactured by Life-Tech. Device Description: The lontophoresis System (IP'S) is a single-use device that employs electr… | 1987 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110636 | Tula Iontophoresis System | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K110636 (Acclarent, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EGJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGJ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGJ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGJ
3in 2025
MAUDE reports naming product code EGJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 104 | 0 | 1 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 21 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Iontophoresis System is indicated for the administration of drug solution, salts, or ions into the ear, including the tympanic membrane, for medical purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073276: Iontophoresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073276
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026