# K953649: Disposable Ecg Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Kendall-Ltp
- Decided: Jun 21, 1996 after 322 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
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 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 its predicate without a number.
- (no number) NDM disposable ECG electrodes: named in the summary without a submission number
- (no number) Nikomed disposable ECG electrodes: named in the summary without a submission number

## Most influential descendants
- K013725: Meditron II Thesterthoscope System (2002), 16 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own
- K121617: Sensicardiac (2012), 10 descendants of its own
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application (2013), 9 descendants of its own
- K181988: eMurmur ID (2019), 7 descendants of its own

## Indications for use
LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product.

Source page: https://510kreport.com/device/K953649
Methodology: https://510kreport.com/methodology