# K974445: 3M Red Dot Resting Ekg Electrode, Catalog 2360

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Jul 26, 1998 after 243 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The 3M Red Dot™ Resting EKG Electrode can be used on a patient undergoing an EKG diagnostic procedure while resting. These electrodes are applied to the patient's skin for short term use. These electrodes are disposable and are for single use. They are not indicated for use in long term monitoring. These electrodes will include the precaution statement: U.S.A. Federal Law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K974445
Methodology: https://510kreport.com/methodology