# K253059: Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

- Pathway: 510(k) (Traditional)
- Applicant: Tournicare Pty, Ltd.
- Decided: Jun 15, 2026 after 266 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: 4 generations back to K052153 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162092: Evolv Model BP7000 Upper Arm Blood Pressure Monitor, Omron Healthcare, Inc. (2016) Summary page 5.

## Indications for use
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).

Source page: https://510kreport.com/device/K253059
Methodology: https://510kreport.com/methodology