# K031115: RH-900

- Pathway: 510(k) (Traditional)
- Applicant: Iomed, Inc.
- Decided: Jul 10, 2003 after 93 days
- Product code: KTB (Device, Iontophoresis, Specific 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: 3 generations back to K912015 (1991). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932620: RH-806/GS Model Transq (R)2, Iomed, Inc. (1994) Summary page 1.
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode, Empi (1998) Summary page 1.

## Most influential descendants
- K033192: RH-950 (2003), 3 descendants of its own
- K063465: Champion Iontophoretic Drug Delivery Device (2007), 1 descendant of its own
- K043047: Dynatron Ibox Iontophoresis Device (2005), 1 descendant of its own
- K170291: IontoDC (2017), 0 descendants of its own
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own

## Indications for use
Iontophoretic drug delivery electrodes 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 HCl 2% and Epinephrine 1:100,000 Topical Solution).

Source page: https://510kreport.com/device/K031115
Methodology: https://510kreport.com/methodology