# K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Nov 15, 1991 after 193 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
No predicates in its family tree.
22 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970491: Dupel II Buffered Iontophoresis Electrodes (1997), 21 descendants of its own
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode (1998), 20 descendants of its own
- 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

Source page: https://510kreport.com/device/K912015
Methodology: https://510kreport.com/methodology