510(k) Report

510(k) · Cleared

Cleared

Champion Iontophoretic Drug Delivery Device

K063465510(k) TraditionalCleared Feb 28, 2007104-day reviewClass II21 CFR 890.5525

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Iomed, Inc. · EGJ Device, Iontophoresis, Other Uses

Cleared on Feb 28, 2007 as substantially equivalent to K974855 (Iomed, Inc., 1998) and 3 other predicates after a 104-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.

Decided
Feb 28, 2007
Review
104 days
Class
Class II
Product code
EGJ
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K912015 (1991). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 1 other ancestor1994: 4 other ancestors1991: 1 other ancestor2007: 1 descendant clearedK912015 · TBD, Empi Buffered Iontophoresis Electroded MDL. 3 · Empi · 1991K970491 · Dupel II Buffered Iontophoresis Electrodes · Empi · 1997K983484 · Dupel B.L.U.E. Small Iontophoresis Electrode · Empi · 1998K031115 · RH-900 · Iomed, Inc. · 2003K033192 · RH-950 · Iomed, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 2 other ancestors 1 generation forward: 1 descendant K033192 · RH-950 · Iomed, Inc. · 2003K031115 · RH-900 · Iomed, Inc. · 2003K983484 · Dupel B.L.U.E. Small Iontophoresis Electrode · Empi · 1998K970491 · Dupel II Buffered Iontophoresis Electrodes · Empi · 1997K912015 · TBD, Empi Buffered Iontophoresis Electroded MDL. 3 · Empi · 1991−50
  1. Root · 5 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
  2. 4 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
  3. 3 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
  4. 2 generations backK031115 RH-900Iomed, Inc. · 2003
  5. 1 generation backK033192 RH-950Iomed, Inc. · 2003
  6. This deviceK063465 Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
  7. Descendant · cites it directly · 0 of its ownK072946 Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K072946Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K912015TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi1991—
−4K970491Dupel II Buffered Iontophoresis ElectrodesEmpi1997—
−3K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi1998—
−2K031115RH-900Iomed, Inc.2003—
−1K033192RH-950Iomed, Inc.2003—
0 (this device)K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc.2007—
+1K072946Hybresis Iontophoresis Drug Delivery SystemEmpi2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199440
199810
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K063465, 1991–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242041 STOPWET iontophoresis apparatus (SW01)score 9.7 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K974855Phoresor II, Model PM900
Summary page 1
…hampion lontophoretic Drug Delivery System Common Name: lontophoresis Drug Delivery Device B. Name of Predicate Device(s) ! Jontophoresis Device: K974855 and K982668 lontophoresis Drug Delivery Device JOMED, Inc. Phoresor® II PM900 * lontophoresis Device: K932621…
Iomed, Inc.1998—
*K982668Phoresor II,Model PM900
Summary page 1
…ophoretic Drug Delivery System Common Name: lontophoresis Drug Delivery Device B. Name of Predicate Device(s) ! Jontophoresis Device: K974855 and K982668 lontophoresis Drug Delivery Device JOMED, Inc. Phoresor® II PM900 * lontophoresis Device: K932621 Jonto…
Iomed, Inc.1999—
*K932621RH-801/GS Model Transq (R)1
Summary page 1
…Device(s) ! Jontophoresis Device: K974855 and K982668 lontophoresis Drug Delivery Device JOMED, Inc. Phoresor® II PM900 * lontophoresis Device: K932621 Jontophoresis Drug Delivery Device IOMED, Inc. TQ1 RH-801/GS * lontophoresis Device: K033192 lontophore…
Iomed, Inc.1994—
*K033192RH-950
Summary page 1
…MED, Inc. Phoresor® II PM900 * lontophoresis Device: K932621 Jontophoresis Drug Delivery Device IOMED, Inc. TQ1 RH-801/GS * lontophoresis Device: K033192 lontophoresis Drug Delivery Electrode IOMED, Inc. RH1-950 C. Device Description An iontophoresis device is a de…
Iomed, Inc.2003—

Also cleared against K974855: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072946Hybresis Iontophoresis Drug Delivery SystemEmpi20070

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 16 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K072946 (Empi, 2007) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K974855.

How does its category compare?

All EGJ devices

EGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · EGJ

1in 2025

2007: 52008: 22009: 22011: 12014: 12015: 22017: 12018: 12019: 12020: 12023: 12024: 12025: 1
2007high 5 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EGJ

104in 2007

2007: 104 days median
2007high 104 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EGJ

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EGJ

3in 2025

2007: 12008: 62009: 102010: 212011: 92012: 82013: 12014: 12015: 22016: 32017: 32018: 82019: 22020: 22022: 12023: 12025: 3
2007high 21 (2010) · low 0 (2021)2025

MAUDE reports naming product code EGJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007510401
20082—06
20092—010
20100—021
20111—09
20120—08
20130—01
20141—01
20152—02
20160—03
20171—03
20181—08
20191—02
20201—02
20210—10
20220—01
20231—01
20241—00
20251—03
20260—0—

What is it indicated for?

Iontophoretic drug delivery devices are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of iONTOCAINE® (Lidocaine HCI 2% and Epinephrine 1:100,000 Topical Solution).

Indications for use as stated in the FDA summary.

Also cleared against K974855

3 other devices cite the same predicate.

  • K031551Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)Vyteris, Inc. · 2003
  • K021222Lad, Model Lad-01Norwood Abbey, Ltd. · 2003
  • K991991Dupel Iontophoresis SystemEmpi · 1999

More from Iomed, Inc.

17 FDA decisions under this applicant name. See the company

  • K060236MW-1000 Iontophoretic Drug Delivery ElectrodeIomed, Inc. · 2006
  • K033192RH-950Iomed, Inc. · 2003
  • K031115RH-900Iomed, Inc. · 2003
  • K001522TRANSQ3Iomed, Inc. · 2000
  • K001410Phoresor Model PM2000Iomed, Inc. · 2000

Recent decisions in EGJ

The EGJ category page

  • K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd. · 2025
  • K241267Hidroxa SE30Hidroxa Medical AB · 2024
  • K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd. · 2023
  • K192749DermadryDermadry Laboratories, Inc. · 2020
  • K191436SaalioSaalmann Medical GmbH & Co. KG · 2019

https://510kreport.com/device/K063465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063465: Champion Iontophoretic Drug Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063465

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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