510(k) Report

510(k) · Cleared

Cleared

Dupel Iontophoresis System

K991991510(k) TraditionalCleared Sep 10, 199988-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 Sep 10, 1999 as substantially equivalent to K970491 (Empi, 1997) and 7 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1991.

Decided
Sep 10, 1999
Review
88 days
Class
Class II
Product code
EGJ
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K912015 (1991). 10 ancestors in all, the oldest K780310 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1998: 1 other ancestor1994: 2 other ancestors1987: 1 other ancestor1978: 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 · 1998197519801985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors K983484 · 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 · 3 generations backK912015 TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 1991
  2. 2 generations backK970491 Dupel II Buffered Iontophoresis ElectrodesEmpi · 1997
  3. 1 generation backK983484 Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998
  4. This deviceK991991 Dupel Iontophoresis SystemEmpi · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K912015TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi1991—
−2K970491Dupel II Buffered Iontophoresis ElectrodesEmpi1997—
−1K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi1998—
0 (this device)K991991Dupel Iontophoresis SystemEmpi1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198710
199110
199420
199810
199910
FIG. 1 — Lineage of K991991, 1991–1999Source: 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? (8)

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
*K970491Dupel II Buffered Iontophoresis Electrodes
Summary page 1
…25 Proprietary Name: Dupel® Iontophoresis Lead Wire Adapter Common Name: Iontophoresis Lead Wire B. Name of Predicate Devices e Empi Dupel II lIontophoresis Electrodes K970491 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and…
Empi1997—
*K912015TBD, Empi Buffered Iontophoresis Electroded MDL. 3
Summary page 1
…re Adapter Common Name: Iontophoresis Lead Wire B. Name of Predicate Devices e Empi Dupel II lIontophoresis Electrodes K970491 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K9…
Empi1991—
*K983484Dupel B.L.U.E. Small Iontophoresis Electrode
Summary page 1
…s Lead Wire B. Name of Predicate Devices e Empi Dupel II lIontophoresis Electrodes K970491 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K982668 C. Device Description . The E…
Empi1998—
*K780310Dermatron Iontophoresis Device
Summary page 1
…tophoresis Electrodes K970491 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K982668 C. Device Description . The Empi Lead Wire Adapter will allow the use of currently marketed…
Motion Control, Inc.1978—
*K872040Phoresor II (TM), Model PM700
Summary page 1
…s Electrodes K970491 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K982668 C. Device Description . The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Ele…
Motion Control, Inc.1987—
*K934335Phoresor II Auto, Model PM800 Modification
Summary page 1
…des K970491 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K982668 C. Device Description . The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes w…
Iomed, Inc.1994—
*K974855Phoresor II, Model PM900
Summary page 1
…91 e Empi lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K982668 C. Device Description . The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other…
Iomed, Inc.1998—
*K982668Phoresor II,Model PM900
Summary page 1
…lontophoresis Buffered Electrodes K912015 e Dupel B.L.U.E. Electrodes K983484 ¢ Jomed Phoresor lIontophoresis Device and Lead wires K780310, K872040, K934335, K974855, K982668 C. Device Description . The Empi Lead Wire Adapter will allow the use of currently marketed Dupel Electrodes with other commerci…
Iomed, Inc.1999—

Also cleared against K970491: 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 8 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
  • None of the 10 ancestors has a recall.
  • 2 other devices also cite its predicate K970491.

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.

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?

Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K970491

2 other devices cite the same predicate.

  • K070427Dupel Transport Iontophoresis SystemEmpi · 2007
  • K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 1998

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
  • K070427Dupel Transport Iontophoresis SystemEmpi · 2007
  • K061650Select Tens, Model 4600SEmpi · 2007

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/K991991 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991991: Dupel Iontophoresis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991991

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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