# K954900: 3M Red Dot Ecg Lead Wires a

- Pathway: 510(k) (Traditional)
- Applicant: Minnesota Mining and Mfg. Co.
- Decided: Jul 15, 1996 after 264 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- 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 K771645 (1977). 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)
- K771645: Electrocardiographic Cablhs & Lead Wire, Tronomed, Inc. (1977) Summary page 1.
- K880320: Electrode Cable, Vital Connections, Inc. (1988) Summary page 1.

## Indications for use
The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.

Source page: https://510kreport.com/device/K954900
Methodology: https://510kreport.com/methodology