# K983689: Blue Sensor Supatab,Disposable Ecg Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Medicotest A/S
- Decided: Jan 15, 1999 after 87 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
No predicates in its family tree.
5 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041026: Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S (2004), 4 descendants of its own
- 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 ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for resting ECG.

Source page: https://510kreport.com/device/K983689
Methodology: https://510kreport.com/methodology