# K990113: Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical A/S
- Decided: Dec 6, 1999 after 327 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950474 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950473: Disposable Ecg Monitoring Electrode, Nikomed U.S.A., Inc. (1995) Summary page 1.
- K950475: Disposable Ecg Monitoring Electrode #4530, #4540, Nikomed U.S.A., Inc. (1995) Summary page 1.
- K950474: Disposable Ecg Monitoring Electrode #4533 32X45MM, Nikomed U.S.A., Inc. (1995) Summary page 1.
- K950480: Disposable Ecg Monitoring Electrode #4539 28X45MM, Nikomed U.S.A., Inc. (1995) Summary page 1.
- K950477: Disposable Ecg Monitoring Electrode #4560 38X60MM, Nikomed U.S.A., Inc. (1995) Summary page 1.

## Recalls of this device
- Mar 11, 2010 · Not classified · Z-1431-2010: In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.

## Indications for use
ECG monitoring electrodes for short term use.

Source page: https://510kreport.com/device/K990113
Methodology: https://510kreport.com/methodology