# K201302: LiveOne

- Pathway: 510(k) (Traditional)
- Applicant: Livemetric (Medical) S.A.
- Decided: May 4, 2022 after 719 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900247 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123446: TL-300 T-Line Non-Invasive Blood Pressure Monitoring System, United States Gtm Medical Devices, Inc. (2012) Summary page 4.
- K020537: TL10 Tensymeter Blood Pressure Monitoring System, Tensys Medical, Inc. (2002) Summary page 4.

## Indications for use
The LiveOne is intended to be used in patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The LiveOne is intended to be used on subjects > 27 years old and who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing the patient’s cardiac health via blood pressure readings in clinic setting by health care professional. LiveOne is intended only for measurement and display; it makes no diagnosis.

Source page: https://510kreport.com/device/K201302
Methodology: https://510kreport.com/methodology