510(k) · Cleared
ClearedPhoresor II,Model PM900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iomed, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Mar 2, 1999 as substantially equivalent to K934335 (Iomed, Inc., 1994) after a 214-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Mar 2, 1999
- Review
- 214 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934335 (1994). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK934335 Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 1994
- This deviceK982668 Phoresor II,Model PM900Iomed, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK063465 Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK072946 Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007
- Descendant · cites it directly · 0 of its ownK031551 Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)Vyteris, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK020476 Medion 6000Selectivemed Components, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK991991 Dupel Iontophoresis SystemEmpi · 1999
Most influential descendants
Showing 5 of 5 · See all- K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007 · cites it directly1descendant
- K072946Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007 · 2 generations on0descendants
- K031551Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)Vyteris, Inc. · 2003 · cites it directly0descendants
- K020476Medion 6000Selectivemed Components, Inc. · 2002 · cites it directly0descendants
- K991991Dupel Iontophoresis SystemEmpi · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934335 | Phoresor II Auto, Model PM800 Modification | Iomed, Inc. | 1994 | — |
| 0 (this device) | K982668 | Phoresor II,Model PM900 | Iomed, Inc. | 1999 | — |
| +1 | K063465 | Champion Iontophoretic Drug Delivery Device | Iomed, Inc. | 2007 | — |
| +2 | K072946 | Hybresis Iontophoresis Drug Delivery System | Empi | 2007 | — |
| +1 | K031551 | Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D) | Vyteris, Inc. | 2003 | — |
| +1 | K020476 | Medion 6000 | Selectivemed Components, Inc. | 2002 | — |
| +1 | K991991 | Dupel Iontophoresis System | Empi | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K934335 | Phoresor II Auto, Model PM800 ModificationSummary page 1…tems Device Name: lTontophoresis Device Tontophoretic Device Modification Phoresor® 11, Model PM900 Predicate Device: lontophoresis Device Phoresor® 11 , Model PM800 K934335 Description of Device: An iontophoresis device is a device that is intended to use a direct current to introduce ions of solubl… | 1994 |
What descends from it? (5)
4 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?
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 Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts and other drugs into the body for medical purposes as an alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle insertion and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982668: Phoresor II,Model PM900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982668
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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