510(k) · Cleared
Recalled · Class II · 2025Iontopatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Birch Point Medical, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Feb 1, 2000 after a 174-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 1, 2000
- Review
- 174 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- 3
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK992708 IontopatchBirch Point Medical, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK030395 Empi Action Patch Iontophoresis SystemEmpi · 2003
- Descendant · 2 generations on · 0 of its ownK132832 Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK091326 ActivapatchActivatek, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK070427 Dupel Transport Iontophoresis SystemEmpi · 2007
- Descendant · cites it directly · 0 of its ownK031769 E-StripEemso, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K030395Empi Action Patch Iontophoresis SystemEmpi · 2003 · cites it directly3descendants
- K132832Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014 · 2 generations on0descendants
- K091326ActivapatchActivatek, Inc. · 2009 · 2 generations on0descendants
- K070427Dupel Transport Iontophoresis SystemEmpi · 2007 · 2 generations on0descendants
- K031769E-StripEemso, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992708 | Iontopatch | Birch Point Medical, Inc. | 2000 | — |
| +1 | K030395 | Empi Action Patch Iontophoresis System | Empi | 2003 | — |
| +2 | K132832 | Activapatch ET Iontophoresis Patch | Activatek, Inc. | 2014 | — |
| +2 | K091326 | Activapatch | Activatek, Inc. | 2009 | — |
| +2 | K070427 | Dupel Transport Iontophoresis System | Empi | 2007 | — |
| +1 | K031769 | E-Strip | Eemso, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2025 | Class II | Z-2197-2025 | Under Investigation by firm | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. |
| May 22, 2025 | Class II | Z-2196-2025 | Under Investigation by firm | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. |
| Nov 10, 2021 | Class III | Z-0454-2022 | Labeling Change Control | The dosage information on the pouch is incorrect; the primary carton label is correct. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030395 (Empi, 2003) has gone furthest, with 3 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.
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 IontoPatch is intended to be used for the administration of soluble salts into the body for medical purposes as an alternative to hypodermic injection. It is intended to be used in situations when it is advisable to avoid both the pain and danger that may be imposed by needle insertion and injection.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992708: Iontopatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992708
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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