# K060661: Mactrode 3

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Apr 7, 2006 after 25 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902176 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902176: Silver Mactrode, Marquette Electronics, Inc. (1990) Summary page 1.

## Indications for use
The Mactrode® 3 is intended for use on adult patients during an ECG electrocardiogram test. The Mactrode® 3 is applied to the patient's skin. The Mactrode® 3 is intended to be used for less than one hour. The Mactrode® 3 is for single patient use. The Mactrode® 3 is intended to be used under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The Mactrode® 3 is intended for use in a professional medical facility, such as a hospital, clinic or doctor's office.

Source page: https://510kreport.com/device/K060661
Methodology: https://510kreport.com/methodology