510(k) · Cleared
ClearedDynatron Ion Iontophoresis Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · EGJ Device, Iontophoresis, Other Uses
Cleared on Jun 14, 2006 as substantially equivalent to K052019 (North Coast Medical, Inc., 2005) after a 79-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Jun 14, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912015 (1991). 12 ancestors in all, the oldest K882554 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 4 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 3 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- 2 generations backK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003 · Recalled
- 1 generation backK052019 North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005
- This deviceK060814 Dynatron Ion Iontophoresis ElectrodeDynatronics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK080580 Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode…Axelgaard Mfg. Co., Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080580Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…Axelgaard Mfg. Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −4 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −3 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| −2 | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | 1 |
| −1 | K052019 | North Coast Buffered Iontophoresis Electrode | North Coast Medical, Inc. | 2005 | — |
| 0 (this device) | K060814 | Dynatron Ion Iontophoresis Electrode | Dynatronics Corp. | 2006 | — |
| +1 | K080580 | Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment… | Axelgaard Mfg. Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K052019 | North Coast Buffered Iontophoresis ElectrodeSummary page 1…III Regulation Nos.: 890.5525 Product Codes: EGJ 2. PREDICATE DEVICES: North Coast Buffered lontophoresis Electrode - cleared under K052019 3. PERFORMANCE STANDARDS: NA 4. DESCRIPTION: The Dynatron® IonTM iontophoresis electrode consists of an active drug deli… | 2005 |
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 |
|---|---|---|---|
| K080580 | Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model… | 2008 | 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 15 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K080580 (Axelgaard Mfg. Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052019.
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 Dynatron® IonTM iontophoresis electrode is indicated to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060814: Dynatron Ion Iontophoresis Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060814
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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