510(k) · Cleared
Recalled · 2005Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selectivemed Components, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on May 20, 2003 as substantially equivalent to K993081 (Selectivemed Components, Inc., 2000) and 4 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1991. 4 later devices descend from it. It has been recalled once.
- Decided
- May 20, 2003
- Review
- 48 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K912015 (1991). 10 ancestors in all, the oldest K882554 (1988). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
- 2 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
- 1 generation backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
- This deviceK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK052019 North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK060814 Dynatron Ion Iontophoresis ElectrodeDynatronics Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK080580 Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode…Axelgaard Mfg. Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK060579 Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K052019North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005 · cites it directly2descendants
- K060814Dynatron Ion Iontophoresis ElectrodeDynatronics Corp. · 2006 · 2 generations on1descendant
- K080580Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…Axelgaard Mfg. Co., Ltd. · 2008 · 2 generations on0descendants
- K060579Comfort/IO Iontophoresis ElectrodesPepin Mfg., Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912015 | TBD, Empi Buffered Iontophoresis Electroded MDL. 3 | Empi | 1991 | — |
| −2 | K970491 | Dupel II Buffered Iontophoresis Electrodes | Empi | 1997 | — |
| −1 | K983484 | Dupel B.L.U.E. Small Iontophoresis Electrode | Empi | 1998 | — |
| 0 (this device) | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | — |
| +1 | K052019 | North Coast Buffered Iontophoresis Electrode | North Coast Medical, Inc. | 2005 | — |
| +2 | K060814 | Dynatron Ion Iontophoresis Electrode | Dynatronics Corp. | 2006 | — |
| +2 | K080580 | Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment… | Axelgaard Mfg. Co., Ltd. | 2008 | — |
| +1 | 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 | 2 | 0 |
| 1994 | 3 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993081 | IO-DriveSummary page 1…Name Manufacturer 510(k) Numb IO-Drive Electrodes Selective Med Components, Inc. K99308 1 TransQe Electrodes Iomed, Inc. K932620 Iogel Electrode… | 2000 |
| * | K932620 | RH-806/GS Model Transq (R)2Summary page 1…ve Electrodes Selective Med Components, Inc. K99308 1 TransQe Electrodes Iomed, Inc. K932620 Iogel Electrodes Iomed, Inc. K93262 1 Dupe1 B.L.U.E.… | 1994 |
| * | K932621 | RH-801/GS Model Transq (R)1Summary page 1…Qe Electrodes Iomed, Inc. K932620 Iogel Electrodes Iomed, Inc. K93262 1 Dupe1 B.L.U.E. Electrodes Empi, Inc. K983484 Meditrode Elect… | 1994 |
| * | K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeSummary page 1…Electrodes Iomed, Inc. K93262 1 Dupe1 B.L.U.E. Electrodes Empi, Inc. K983484 Meditrode Electrodes Life-Tech, Inc. K882554 1 Add ress : South… | 1998 |
| * | K882554 | Meditrode KitSummary page 1…B.L.U.E. Electrodes Empi, Inc. K983484 Meditrode Electrodes Life-Tech, Inc. K882554 1 Add ress : South Mechanic Street ount Vernon, OH 43050 I Toll Free Phone: 800-62 1-3425… | 1988 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2005 | Not classified | Z-0799-05 | Other | The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K052019 (North Coast Medical, Inc., 2005) has gone furthest, with 2 descendants of its own.
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?
Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031053
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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