# K150289: Cardioline HD+

- Pathway: 510(k) (Traditional)
- Applicant: Cardioline S.P.A
- Decided: Aug 27, 2015 after 203 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002074 (2000). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 4.
- K082124: Carditte Microtel, Et Medical Devices Spa (2009) Summary page 4.

## Most influential descendants
- K223670: MESI mTablet ECG Diagnostic System, MESI mTablet ECG (2023), 0 descendants of its own
- K220526: HD+12, HD+15 (2023), 0 descendants of its own
- K171019: ScioCardio ECG Transmitter (2018), 0 descendants of its own

## Indications for use
HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired. HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition. HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without cable connected to the processing unit). The HD+ transmits the acquired physiological signals in real-time to a computer/device where a compatible application is installed. All data acquired are sent via Bluetooth to a receiver that it can be a PC, tablet or device capable of receiving BT data. The ECG is transmitted verbatim to the receiving system, without LSB or sampling adjustment. It is up to the receiving system/application to perform the necessary processing such as (but not limited to) LSB scaling, signal filtering, Resting ECG analysis etc… The device HD+ is intended to be used on adult and on all pediatric patients. The device is intended for use by qualified, trained nurses and physicians operating in hospitals, clinics and medical practices.

Source page: https://510kreport.com/device/K150289
Methodology: https://510kreport.com/methodology