# K990111: Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570

- 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950470 (1995). 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)
- K950470: Disposable Ecg Monitoring Electrode #4535 32X45MM, Nikomed U.S.A., Inc. (1995) Summary page 1.
- K950478: Disposable Ecg Monitoring Electrode #4570 38X60MM, Nikomed U.S.A., Inc. (1995) Summary page 1.

## Indications for use
Short-term (< 24 hrs) ECG monitoring of infants in operating room and emergency situations (Model 4570); short-term (< 24 hrs) ECG monitoring of infants and neonates in operating room and emergency situations (Model 4520); short-term (< 24 hrs) ECG monitoring of adults and infants under anesthesia (Model 4535).

Source page: https://510kreport.com/device/K990111
Methodology: https://510kreport.com/methodology