# K101576: Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Team Innovations, Inc.
- Decided: Jul 22, 2010 after 45 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 K932454 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932454: 3M Red Dot 2330 Resting Ekg Electrode, 3M Health Care, Ltd. (1993) Summary page 1.
- K964213: Trace Rite Solid Gel Ecg Electrodes, Bio-Detek, Inc. (1996) Summary page 1.

## Indications for use
The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECO use (CenterRidge Diagnostic ECO Electrode) and one for monitoring ECG use (CenterRidge Monitorig-ECG Electrode). The CenterRidge Diagnostic ECQ Electrode is a diagnostic, single use (single patient). disposable ECO electrode. This electrode is intended to acquire ECG signals from the surface of the body, The intended poptiation is adults and pediatrics. The intended duration of body contact is less than 24 hours. The CenterRidgt Monitoring ECG Electrode is a monitoring, single use (single patient), disposable ECO electrode. This electrode is intended to acquire ECO signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.

Source page: https://510kreport.com/device/K101576
Methodology: https://510kreport.com/methodology