510(k) · Cleared
ClearedMedion 6000
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 3, 2002 as substantially equivalent to K982668 (Iomed, Inc., 1999) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- May 3, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K934335 (1994). 3 ancestors in all, the oldest K895365 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934335 | Phoresor II Auto, Model PM800 Modification | Iomed, Inc. | 1994 | — |
| −1 | K982668 | Phoresor II,Model PM900 | Iomed, Inc. | 1999 | — |
| 0 (this device) | K020476 | Medion 6000 | Selectivemed Components, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982668 | Phoresor II,Model PM900Summary page 1…Device, 21 CFR 890.5525, Code EGJ Common or usual name: Iontophoresis Device Proprietary Name: Medion™ 6000 Series B.N ¢ Predicate Devi Iomed Phoresor I Model PM 900 K982668 Iomed Phoresor I Model PM 800 K933445* R. A. Fischer MD-2 Iontophoresis Unit K895365 C Device D otion: The iontophoresis device… | 1999 |
| Kept off the family tree | K933445 | FDA’s K933445 is DPS 100 Multiport Illumination System (Mis) Our OCR of the scanned summary read K933445, FDA’s number for DPS 100 Multiport Illumination System (Mis) (Storz Instrument Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Iomed Phoresor I Model PM 800”. Kept off the family tree. Summary page 1…mmon or usual name: Iontophoresis Device Proprietary Name: Medion™ 6000 Series B.N ¢ Predicate Devi Iomed Phoresor I Model PM 900 K982668 Iomed Phoresor I Model PM 800 K933445* R. A. Fischer MD-2 Iontophoresis Unit K895365 C Device D otion: The iontophoresis device is intended to use a direct current to… | 1994 |
| * | K895365 | MD-2 Iontophoresis UnitSummary page 1…ietary Name: Medion™ 6000 Series B.N ¢ Predicate Devi Iomed Phoresor I Model PM 900 K982668 Iomed Phoresor I Model PM 800 K933445* R. A. Fischer MD-2 Iontophoresis Unit K895365 C Device D otion: The iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K982668.
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?
Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.
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/K020476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020476: Medion 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020476
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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