510(k) · Cleared
ClearedE-Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eemso, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Oct 14, 2003 as substantially equivalent to K872040 (Motion Control, Inc., 1987) and 2 other predicates after a 127-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Oct 14, 2003
- Review
- 127 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K872040 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872040 Phoresor II (TM), Model PM700Motion Control, Inc. · 1987
- This deviceK031769 E-StripEemso, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872040 | Phoresor II (TM), Model PM700 | Motion Control, Inc. | 1987 | — |
| 0 (this device) | K031769 | E-Strip | Eemso, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 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? (4)
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 |
|---|---|---|---|
| * | K872040 | Phoresor II (TM), Model PM700Summary page 1…ification: Iontophoresis Device 21 C.F.R. 890.5525 (b) 111 Predicate Devices Iomed Phoresor I1 Model PM 700 K872040 With Trans Q 2 electrodes K9 14264 Life-Tech Iontophor I1 Model 6 1 11 PMDX ????????… | 1987 |
| * | K914264 | Transq 2Summary page 1…21 C.F.R. 890.5525 (b) 111 Predicate Devices Iomed Phoresor I1 Model PM 700 K872040 With Trans Q 2 electrodes K9 14264 Life-Tech Iontophor I1 Model 6 1 11 PMDX ???????? With Meditrode electrodes Ionto Patch… | 1991 |
| * | K992708 | IontopatchSummary page 1…K9 14264 Life-Tech Iontophor I1 Model 6 1 11 PMDX ???????? With Meditrode electrodes Ionto Patch K992708 IV Device Description The E-STRIP is an active; self- contained Iontophoretic Drug Delivery System. An Integrated batte… | 2000 |
| * | — | Life-Tech Iontophor II Model 6111 PMDX with Meditrode electrodes Named without a submission number |
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?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K872040.
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 E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031769: E-Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031769
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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