# K970796: 3M Red Dot 2560 & 2570 Monitoring Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Apr 9, 1997 after 36 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062760: Ori F6T Dry Ecg Monitoring Electrode (2006), 0 descendants of its own

## Recalls of this device
- Sep 15, 2020 · Class II · Z-0421-2021: Corrosion could cause performance failures in the product.
- Sep 15, 2020 · Class II · Z-0423-2021: Corrosion could cause performance failures in the product.
- Sep 15, 2020 · Class II · Z-0422-2021: Corrosion could cause performance failures in the product.
- Sep 15, 2020 · Class II · Z-0419-2021: Corrosion could cause performance failures in the product.
- Sep 15, 2020 · Class II · Z-0420-2021: Corrosion could cause performance failures in the product.
- Jul 27, 2010 · Not classified · Z-2383-2010: The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is nece

## Indications for use
The 3M Red Dot™ 2560 & 2570 Monitoring Electrodes are intended for use in ECG Monitoring. The 2560 and 2570 electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 5 Days) monitoring.

Source page: https://510kreport.com/device/K970796
Methodology: https://510kreport.com/methodology