510(k) · Cleared
ClearedTula Iontophoresis 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 Jun 16, 2011 as substantially equivalent to K073276 (Acclarent, Inc., 2008) after a 104-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Jun 16, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K870272 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK870272 Model 6110C OtophorLife-Tech Intl., Inc. · 1987
- 1 generation backK073276 Iontophoresis SystemAcclarent, Inc. · 2008
- This deviceK110636 Tula Iontophoresis SystemAcclarent, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK150453 TULA Iontophoresis System with EarsetAcclarent, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150453TULA Iontophoresis System with EarsetAcclarent, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870272 | Model 6110C Otophor | Life-Tech Intl., Inc. | 1987 | — |
| −1 | K073276 | Iontophoresis System | Acclarent, Inc. | 2008 | — |
| 0 (this device) | K110636 | Tula Iontophoresis System | Acclarent, Inc. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K073276 | Iontophoresis SystemSummary page 1…n Number: 21 CFR 890.5525 Classification Name: Device, lontophoresis, Specific Uses Product Code: EGI Predicate Device: lontophoresis System (K073276) manufactured by Acciarent Device Description: The lontophoresis System with Headset (IPSHS) is a single-use device that… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150453 | TULA Iontophoresis System with Earset | 2015 | 0 |
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 24 years and passes through 2 companies; a new generation was cleared every 20.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150453 (Acclarent, Inc., 2015) has gone furthest, with 0 descendants 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. 2011, 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 Headset 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/K110636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110636: Tula Iontophoresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110636
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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