# K220526: HD+12, HD+15

- Pathway: 510(k) (Traditional)
- Applicant: Cardioline S.P.A
- Decided: May 15, 2023 after 445 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- 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: 4 generations back to K002074 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150289: Cardioline HD+, Cardioline S.P.A (2015) Summary page 5.

## Recalls of this device
- Jul 20, 2026 · Class II · Z-3013-2026: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

## Indications for use
The function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient’s conditions. HD+ is a wireless or USB (with appropriate option) ECG acquisition device, to be used primarily as common front-end for standard PC/tablet platforms (Windows/MAC OS/others), for resting ECG applications. The device implements wireless communication via Bluetooth wireless technology or wired with USB communication. With both connection modes, HD+ sends the data to the receiver device without performing any analysis or filtering. HD+ is not intended for monitoring or analysis of the cardiac function or to diagnose the patient’s health condition. Display, print and analysis applications on the receiver device are separate products. HD+ is not able to permanently store the acquired data, therefore it does not work unless a connection has been established with a receiver application. Furthermore, HD+ does not collect any of the patient’s sensitive data (patient’s name, age, previous health conditions etc.). HD+ detects the QRS complexes and transmit the results to the receiving device. The QRS detection function is intended for patients aged 12 years or older. *HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG’s and rhythm strips *HD+ is suitable for working at high altitudes, with restrictions. *HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older *HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances). *HD+ is intended for use by a physician, nurse or other healthcare professional (e.g., ECG technician) who acts following orders by a physician or authorized nurse, including when operated in home environments *HD+ is not intended for real-time monitoring of vital physiological parameters.

Source page: https://510kreport.com/device/K220526
Methodology: https://510kreport.com/methodology