510(k) Report

510(k) · Cleared

Cleared

Dupel Transport Iontophoresis System

K070427510(k) TraditionalCleared May 14, 200790-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

Empi · EGJ Device, Iontophoresis, Other Uses

Cleared on May 14, 2007 as substantially equivalent to K030395 (Empi, 2003) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1991.

Decided
May 14, 2007
Review
90 days
Class
Class II
Product code
EGJ
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K912015 (1991). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestors2000: 1 other ancestor1991: 1 other ancestorK912015 · 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 · 1998K030395 · Empi Action Patch Iontophoresis System · Empi · 20031990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors K030395 · Empi Action Patch Iontophoresis System · Empi · 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 · 19910
  1. Root · 4 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
  2. 3 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
  3. 2 generations backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
  4. 1 generation backK030395 Empi Action Patch Iontophoresis SystemEmpi · 2003
  5. This deviceK070427 Dupel Transport Iontophoresis SystemEmpi · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K912015TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi1991—
−3K970491Dupel II Buffered Iontophoresis ElectrodesEmpi1997—
−2K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi1998—
−1K030395Empi Action Patch Iontophoresis SystemEmpi2003—
0 (this device)K070427Dupel Transport Iontophoresis SystemEmpi2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420
200010
FIG. 1 — Lineage of K070427, 1991–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K030395Empi Action Patch Iontophoresis System
Summary page 1
…vice (21 CFR 890.5525) Product Code: EGJ Classification: Class III Predicate devices: Empi Action Patch® Jontophoresis System (K030395), Empi Dupel® lontophoresis System (K915444), Empi Dupel B.L.U.E. ® l…
Empi2003—
*K915444Dupel Iontophoresis Device
Summary page 1
…Class III Predicate devices: Empi Action Patch® Jontophoresis System (K030395), Empi Dupel® lontophoresis System (K915444), Empi Dupel B.L.U.E. ® lontophoresis Electrode (K970491, K983484) Device Description: The Empi Du…
Empi1994—
*K970491Dupel II Buffered Iontophoresis Electrodes
Summary page 1
…System (K030395), Empi Dupel® lontophoresis System (K915444), Empi Dupel B.L.U.E. ® lontophoresis Electrode (K970491, K983484) Device Description: The Empi Dupel Transport Jontophoresis System is a disposable, single-use iontophoresis device wit…
Empi1997—
*K983484Dupel B.L.U.E. Small Iontophoresis Electrode
Summary page 1
…K030395), Empi Dupel® lontophoresis System (K915444), Empi Dupel B.L.U.E. ® lontophoresis Electrode (K970491, K983484) Device Description: The Empi Dupel Transport Jontophoresis System is a disposable, single-use iontophoresis device with a self-…
Empi1998—

Also cleared against K030395: 2 other devices →

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 16 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K030395.

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?

The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.

Indications for use as stated in the FDA summary.

Also cleared against K030395

2 other devices cite the same predicate.

  • K132832Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
  • K091326ActivapatchActivatek, Inc. · 2009

More from Empi

60 FDA decisions under this applicant name. See the company

  • K093324Empi ContinuumEmpi · 2010
  • K090922Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
  • K072946Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007
  • K061650Select Tens, Model 4600SEmpi · 2007
  • K041920Infinity Plus Electrotherapy SystemEmpi · 2005

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/K070427 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070427: Dupel Transport Iontophoresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070427

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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