# K983484: Dupel B.L.U.E. Small Iontophoresis Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Dec 28, 1998 after 84 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912015 (1991). 4 ancestors in all.
20 later devices descend from it; 8 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970491: Dupel II Buffered Iontophoresis Electrodes, Empi (1997) Summary page 1.
- K914621: Iontophoresis Device, Modification, Iomed, Inc. (1991) Summary page 1.
- K925806: RH-801, Model Transq, Iomed, Inc. (1994) Summary page 1.
- K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3, Empi (1991) Summary page 1.

## Most influential descendants
- K031115: RH-900 (2003), 6 descendants of its own
- K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405 (2004), 5 descendants of its own
- K031053: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7 (2003), 4 descendants of its own
- K033192: RH-950 (2003), 3 descendants of its own
- K030395: Empi Action Patch Iontophoresis System (2003), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K983484
Methodology: https://510kreport.com/methodology