510(k) · Cleared
ClearedTournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tournicare Pty, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 15, 2026 as substantially equivalent to K162092 (Omron Healthcare, Inc., 2016) after a 266-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Jun 15, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K052153 (2005). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK052153 Omron Automatic Blood Pressure Monitor, Model Hem-741CRELOmron Healthcare, Inc. · 2005
- 3 generations backK121932 Hem-7200-Z (BP742)Omron Healthcare, Inc. · 2012
- 2 generations backK133383 HEM-7320Omron Healthcare, Inc. · 2014
- 1 generation backK162092 Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. · 2016
- This deviceK253059 Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K052153 | Omron Automatic Blood Pressure Monitor, Model Hem-741CREL | Omron Healthcare, Inc. | 2005 | — |
| −3 | K121932 | Hem-7200-Z (BP742) | Omron Healthcare, Inc. | 2012 | — |
| −2 | K133383 | HEM-7320 | Omron Healthcare, Inc. | 2014 | — |
| −1 | K162092 | Evolv Model BP7000 Upper Arm Blood Pressure Monitor | Omron Healthcare, Inc. | 2016 | — |
| 0 (this device) | K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K162092 | Evolv Model BP7000 Upper Arm Blood Pressure MonitorSummary page 5…870.1130 Product Code(s) DXN | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K162092 Omron Evolv Model BP7000 Upper Arm Blood Pressure Monitor | | DXN Device Description Summary 21 CFR 807.92(a)(4) The ARMA Blood… | 2016 |
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 21 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K162092.
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. 2026, 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 ARMA automatic Blood Pressure Monitor is indicated for home use for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is clamped to the upper arm. The intended upper arm circumference is 24 cm to 36 cm (9.4 in to 14.2 in).
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/K253059 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253059: Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253059
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026