FDA 510(k) · LiveMetric
K201302: LiveOne (Livemetric (Medical) S.A.)
Livemetric (Medical) S.A. received FDA 510(k) K201302 for LiveOne, with a decision date of May 4, 2022 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K201302 |
|---|---|
| Pathway | 510(k) |
| Applicant | Livemetric (Medical) S.A. |
| Device name | LiveOne |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | May 15, 2020 |
| Decision date | May 4, 2022 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The LiveOne is intended to be used in patients who have a need for a non-invasive 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 taken in a clinical setting by health care professional . LiveOne is intended only for measurement and display; it makes no diagnosis.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K201302
- K254000 Happy Health Blood Pressure Monitor (Happy Health, Sep 3, 2026, DXN)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Other. These are heuristics, not FDA fields.