# K971444: 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: 3M Medical Products Group
- Decided: Jun 11, 1997 after 51 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 K930312 (1993). 1 ancestor in all.
4 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)
- K930312: 3M Red Dot 2234 Radiolucent Monitoring Electrode, 3M Health Care, Ltd. (1993). Our OCR of the scanned summary read K939312, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode”.

## Most influential descendants
- K040249: Skintact Ecg Electrode (2004), 3 descendants of its own
- K073104: Skintact and Various Other Tradenames (2007), 2 descendants of its own
- K090496: Qwiklead Reusable Electrocardiograph Electrode Patch (2009), 0 descendants of its own
- K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive (2008), 0 descendants of its own

## Indications for use
The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring. The 2234 and 2266 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 3 days) monitoring. These devices are a single use, non-sterile, and disposable ECG electrode. These devices adhere to the patient's skin. These electrodes will include the precaution statement: USA Federal Law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K971444
Methodology: https://510kreport.com/methodology