# K160746: CARDIOLINE touchECG

- Pathway: 510(k) (Traditional)
- Applicant: Cardioline S.P.A
- Decided: Nov 2, 2016 after 229 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: 33 generations back to K941811 (1994). 207 ancestors in all.
No later device cites it as a predicate yet.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120865: Rscribe Electrocardiograph, Mortara Instrument, Inc. (2012) Summary page 4.
- K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2016) Summary page 4.

## Indications for use
touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG. touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances). touchECG is intended to be used in conjunction with CARDIOLINE HD+ device. - The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device. - The device interprets the data for review by a physician. - The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis. - The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data. - The device can be used on adults patients. - The device must not be used as a physiological monitoring of vital signs.

Source page: https://510kreport.com/device/K160746
Methodology: https://510kreport.com/methodology