510(k) · Cleared
ClearedComfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axelgaard Mfg. Co., Ltd. · EGJ Device, Iontophoresis, Other Uses
Cleared on Jun 18, 2008 as substantially equivalent to K052019 (North Coast Medical, Inc., 2005) and 1 other predicate after a 107-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jun 18, 2008
- Review
- 107 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K912015 (1991). 13 ancestors in all, the oldest K882554 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 5 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 4 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- 3 generations backK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003 · Recalled
- 2 generations backK052019 North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005
- 1 generation backK060814 Dynatron Ion Iontophoresis ElectrodeDynatronics Corp. · 2006
- This deviceK080580 Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode…Axelgaard Mfg. Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −5 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −4 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| −3 | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | 1 |
| −2 | K052019 | North Coast Buffered Iontophoresis Electrode | North Coast Medical, Inc. | 2005 | — |
| −1 | K060814 | Dynatron Ion Iontophoresis Electrode | Dynatronics Corp. | 2006 | — |
| 0 (this device) | 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 |
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? (2)
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…Manufacturer/Distributor 510(k) Number Buffered lontophoresis Drug Delivery Electrodes North Coast Medical K052019 Dynatron Ion Dynatronics K060814 Device Description Comfo… | 2005 |
| * | K060814 | Dynatron Ion Iontophoresis ElectrodeSummary page 1…Drug Delivery Electrodes North Coast Medical K052019 Dynatron Ion Dynatronics K060814 Device Description Comfort Iontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) consist of an active dru… | 2006 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 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. 2008, 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?
Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080580: Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model Small DDS275, Medium DDM325, Large D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080580
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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