510(k) · Cleared
ClearedNorth Coast Buffered Iontophoresis Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North Coast Medical, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Nov 4, 2005 as substantially equivalent to K031053 (Selectivemed Components, Inc., 2003) and 3 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Nov 4, 2005
- Review
- 101 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K912015 (1991). 11 ancestors in all, the oldest K882554 (1988). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK052019 North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK060814 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 2 of 2 · See allView 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) | K052019 | North Coast Buffered Iontophoresis Electrode | North Coast Medical, Inc. | 2005 | — |
| +1 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Summary page 1…e Manufacturer 510(k Number Buffered lontophoresis Drug Delivery Electrodes Selective Med Components K031053 TransQe Electrodes lomed, Inc. K932620 logel Electrodes… | 2003 |
| * | K932620 | RH-806/GS Model Transq (R)2Summary page 1…ered lontophoresis Drug Delivery Electrodes Selective Med Components K031053 TransQe Electrodes lomed, Inc. K932620 logel Electrodes lomed, Inc. K932621 Dupel B.L.U.E. Electrodes… | 1994 |
| * | K932621 | RH-801/GS Model Transq (R)1Summary page 1…sQe Electrodes lomed, Inc. K932620 logel Electrodes lomed, Inc. K932621 Dupel B.L.U.E. Electrodes Empi, Inc. K983484… | 1994 |
| * | K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeSummary page 1…l Electrodes lomed, Inc. K932621 Dupel B.L.U.E. Electrodes Empi, Inc. K983484 D-1 Device Description North Coast Buffered lontophoresis… | 1998 |
What descends from it? (2)
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)
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 14 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K060814 (Dynatronics Corp., 2006) has gone furthest, with 1 descendant of its own.
- 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?
Iontophoresis is indicated 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/K052019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052019: North Coast Buffered 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/K052019
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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