# K160840: ECG100+, ECG200+

- Pathway: 510(k) (Traditional)
- Applicant: Cardioline S.P.A
- Decided: Aug 12, 2016 after 137 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933143 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051534: Cardioline AR 600, AR 1200, AR 2100, Et Medical Devices Spa (2005) Summary page 4.
- K101403: Eli 250 Electrocardiograph, Mortara Instrument, Inc. (2010) Summary page 4.

## Indications for use
ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer. ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician. ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size. - The device is indicated for use to acquire, analyse, display and print electrocardiograms. - The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed by a physician. - The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. - The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. - The device is indicated for use on adult and pediatric populations. - The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K160840
Methodology: https://510kreport.com/methodology