# K041026: Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Jun 28, 2004 after 68 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 K983689 (1999). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K983689: Blue Sensor Supatab,Disposable Ecg Electrodes, Medicotest A/S (1999) Summary page 2.

## Most influential descendants
- K140862: Monica Novii Wireless Patch System (2014), 3 descendants of its own
- K231964: Novii+ Wireless Patch System (2023), 1 descendant of its own
- K254036: Novii+ Wireless Patch System (2026), 0 descendants of its own
- K233440: Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (2024), 0 descendants of its own

## Indications for use
The MRX disposable ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram. The electrode is designed for use in MR environment and made for X-ray purposes, therefbre the electrode is MR safe and X-ray translucent. The electrode is made for single patient use only.

Source page: https://510kreport.com/device/K041026
Methodology: https://510kreport.com/methodology