# K990112: Disposable Ecg Monitoring Electrodes, Models 4060, 4610

- 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 K950479 (1995). 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)
- K950479: Disposable Ecg Monitoring Electrode #4600 60MM, #4610 45MM, Nikomed U.S.A., Inc. (1995) Summary page 2.

## Indications for use
ECG monitoring electrodes for short-term use (<24 hours) in adults (Model 4060) and infants (Model 4610).

Source page: https://510kreport.com/device/K990112
Methodology: https://510kreport.com/methodology