510(k) · Cleared
ClearedTBD, Empi Buffered Iontophoresis Electrodes MDL. 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · EGJ Device, Iontophoresis, Other Uses
Cleared on Oct 28, 1991 after a 175-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 28, 1991
- Review
- 175 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK912014 TBD, Empi Buffered Iontophoresis Electrodes MDL. 2Empi · 1991
- Descendant · cites it directly · 5 of its ownK993081 IO-DriveSelectivemed Components, Inc. · 2000
- Descendant · 2 generations on · 4 of its ownK031053 Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery…Selectivemed Components, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 2 of its ownK052019 North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005
- Descendant · 4 generations on · 1 of its ownK060814 Dynatron Ion Iontophoresis ElectrodeDynatronics Corp. · 2006
- Descendant · 4 generations on · 0 of its ownK080580 Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode…Axelgaard Mfg. Co., Ltd. · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K993081IO-DriveSelectivemed Components, Inc. · 2000 · cites it directly5descendants
- K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes…Selectivemed Components, Inc. · 2003 · 2 generations on4descendants
- K052019North Coast Buffered Iontophoresis ElectrodeNorth Coast Medical, Inc. · 2005 · 3 generations on2descendants
- K060814Dynatron Ion Iontophoresis ElectrodeDynatronics Corp. · 2006 · 4 generations on1descendant
- K080580Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment, Model…Axelgaard Mfg. Co., Ltd. · 2008 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912014 | TBD, Empi Buffered Iontophoresis Electrodes MDL. 2 | Empi | 1991 | — |
| +1 | K993081 | IO-Drive | Selectivemed Components, Inc. | 2000 | — |
| +2 | K031053 | Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System… | Selectivemed Components, Inc. | 2003 | 1 |
| +3 | K052019 | North Coast Buffered Iontophoresis Electrode | North Coast Medical, Inc. | 2005 | — |
| +4 | K060814 | Dynatron Ion Iontophoresis Electrode | Dynatronics Corp. | 2006 | — |
| +4 | K080580 | Comfort Iontophoresis Electrodes/ Buffered Iontophoresis Electrode Treatment… | Axelgaard Mfg. Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993081 | IO-Drive | 2000 | 5 |
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?
- Of its descendants, K993081 (Selectivemed Components, Inc., 2000) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K912014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K912014: TBD, Empi Buffered Iontophoresis Electrodes MDL. 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912014
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026