# K033192: RH-950

- Pathway: 510(k) (Traditional)
- Applicant: Iomed, Inc.
- Decided: Dec 22, 2003 after 81 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: 4 generations back to K912015 (1991). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031115: RH-900, Iomed, Inc. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K990318: Birch Point IontoPatch Iontophoresis Drug Delivery Electrode. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K063465: Champion Iontophoretic Drug Delivery Device (2007), 1 descendant of its own
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own
- K072946: Hybresis Iontophoresis Drug Delivery System (2007), 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/K033192
Methodology: https://510kreport.com/methodology