# K992708: Iontopatch

- Pathway: 510(k) (Traditional)
- Applicant: Birch Point Medical, Inc.
- Decided: Feb 1, 2000 after 174 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030395: Empi Action Patch Iontophoresis System (2003), 3 descendants of its own
- K132832: Activapatch ET Iontophoresis Patch (2014), 0 descendants of its own
- K091326: Activapatch (2009), 0 descendants of its own
- K070427: Dupel Transport Iontophoresis System (2007), 0 descendants of its own
- K031769: E-Strip (2003), 0 descendants of its own

## Recalls of this device
- May 22, 2025 · Class II · Z-2197-2025: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- May 22, 2025 · Class II · Z-2196-2025: The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
- Nov 10, 2021 · Class III · Z-0454-2022: The dosage information on the pouch is incorrect; the primary carton label is correct.

## Indications for use
The IontoPatch is intended to be used for the administration of soluble salts into the body for medical purposes as an alternative to hypodermic injection. It is intended to be used in situations when it is advisable to avoid both the pain and danger that may be imposed by needle insertion and injection.

Source page: https://510kreport.com/device/K992708
Methodology: https://510kreport.com/methodology