510(k) · Cleared
ClearedComfort/IO Iontophoresis Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pepin Mfg., Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Apr 20, 2006 as substantially equivalent to K031053 (Selectivemed Components, Inc., 2003) and 3 other predicates after a 45-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Apr 20, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K912015 (1991). 14 ancestors in all, the oldest K882554 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 3 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 2 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- 1 generation backK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003 · Recalled
- This deviceK060579 Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −3 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −2 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| −1 | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | 1 |
| 0 (this device) | K060579 | Comfort/IO Iontophoresis Electrodes | Pepin Mfg., Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1994 | 4 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Summary page 1…/10 lontophoresis Electrodes Classification Name: 21 CFR 890.5525, lontophoresis Device Predicate Device(s): 510(k) Number: K031053 Manufacture: Selective Med Components, Inc. Trade Name: Buffer… | 2003 |
| * | K914264 | Transq 2Summary page 1…Med Components, Inc. Trade Name: Buffered lontophoresis Drug Delivery System Electrodes 510(k) Number: K914264, K925800, K933620 Manufacture: Joined, Inc. Trade Name: lontop… | 1991 |
| * | K925800 | RH-806, Model TransqSummary page 1…onents, Inc. Trade Name: Buffered lontophoresis Drug Delivery System Electrodes 510(k) Number: K914264, K925800, K933620 Manufacture: Joined, Inc. Trade Name: lontophoresis D… | 1994 |
| Kept off the family tree | K933620 | Iontophoresis Drug Delivery Electrodes Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…nc. Trade Name: Buffered lontophoresis Drug Delivery System Electrodes 510(k) Number: K914264, K925800, K933620 Manufacture: Joined, Inc. Trade Name: lontophoresis Drug Deliv… | |
| * | K040495 | Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402…Summary page 1…Manufacture: Joined, Inc. Trade Name: lontophoresis Drug Delivery Electrodes 510(k) Number: K040495 Manufacture: North American Industrial Manufacturing Company Trade… | 2004 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K031053.
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 Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060579: Comfort/IO Iontophoresis Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060579
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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