510(k) · Cleared
ClearedTULA Iontophoresis System with Earset
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 May 20, 2015 as substantially equivalent to K110636 (Acclarent, Inc., 2011) after an 89-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- May 20, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K870272 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870272 | Model 6110C Otophor | Life-Tech Intl., Inc. | 1987 | — |
| −2 | K073276 | Iontophoresis System | Acclarent, Inc. | 2008 | — |
| −1 | K110636 | Tula Iontophoresis System | Acclarent, Inc. | 2011 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K110636 | Tula Iontophoresis SystemSummary page 5….5525 Classification Name: Device, Iontophoresis, Other Purposes Product Code: EGJ Predicate Device: Iontophoresis System with Headset or IPSHS (K110636) manufactured by Acclarent Device Description: The Acclarent Iontophoresis System with Earset (IPS… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 with Earset 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/K150453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150453: TULA Iontophoresis System with Earset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150453
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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