510(k) · Cleared
ClearedPhoresor II Auto, Model PM800 Modification
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 Jul 26, 1994 after a 322-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jul 26, 1994
- Review
- 322 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK934335 Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK974855 Phoresor II, Model PM900Iomed, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK982668 Phoresor II,Model PM900Iomed, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK063465 Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK021222 Lad, Model Lad-01Norwood Abbey, Ltd. · 2003
- Descendant · 3 generations on · 0 of its ownK072946 Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K974855Phoresor II, Model PM900Iomed, Inc. · 1998 · cites it directly6descendants
- K982668Phoresor II,Model PM900Iomed, Inc. · 1999 · cites it directly5descendants
- K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007 · 2 generations on1descendant
- K021222Lad, Model Lad-01Norwood Abbey, Ltd. · 2003 · 2 generations on1descendant
- K072946Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934335 | Phoresor II Auto, Model PM800 Modification | Iomed, Inc. | 1994 | — |
| +1 | K974855 | Phoresor II, Model PM900 | Iomed, Inc. | 1998 | — |
| +1 | K982668 | Phoresor II,Model PM900 | Iomed, Inc. | 1999 | — |
| +2 | K063465 | Champion Iontophoretic Drug Delivery Device | Iomed, Inc. | 2007 | — |
| +2 | K021222 | Lad, Model Lad-01 | Norwood Abbey, Ltd. | 2003 | — |
| +3 | K072946 | Hybresis Iontophoresis Drug Delivery System | Empi | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 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?
- Of its descendants, K974855 (Iomed, Inc., 1998) has gone furthest, with 6 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/K934335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934335: Phoresor II Auto, Model PM800 Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934335
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026