510(k) · Cleared
ClearedLiveOne
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livemetric (Medical) S.A. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 4, 2022 as substantially equivalent to K123446 (United States Gtm Medical Devices, Inc., 2012) and 1 other predicate after a 719-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- May 4, 2022
- Review
- 719 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900247 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure System | Colin Medical Instruments Corp. | 1990 | — |
| −1 | K020537 | TL10 Tensymeter Blood Pressure Monitoring System | Tensys Medical, Inc. | 2002 | — |
| 0 (this device) | K201302 | LiveOne | Livemetric (Medical) S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123446 | TL-300 T-Line Non-Invasive Blood Pressure Monitoring SystemSummary page 4…d for marketing: Device Name Manufacturer 510(K) TL300 Tensymeter Noninvasive Tensys Medical, Inc. K123446 Blood Pressure Monitor TL10 Tensymeter Non-invasive Tensys Medical, Inc. K020537 Blood Pressure Monitor… | 2012 |
| * | K020537 | TL10 Tensymeter Blood Pressure Monitoring SystemSummary page 4…ensymeter Noninvasive Tensys Medical, Inc. K123446 Blood Pressure Monitor TL10 Tensymeter Non-invasive Tensys Medical, Inc. K020537 Blood Pressure Monitor Page 1 of 8… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201302 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201302: LiveOne.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201302
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026