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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K253059

510(k) cleared

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

Tournicare Pty, Ltd. · Jun 15, 2026 · K253059

FDA cleared the Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) from Tournicare Pty, Ltd. on Jun 15, 2026 under K253059, a traditional 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 22, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Tournicare Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253059?

K253059 is the FDA 510(k) for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08), submitted by Tournicare Pty, Ltd.. FDA's decision date was Jun 15, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

Tournicare Pty, Ltd., based in Balwyn, is the applicant of record for K253059.

How long did the K253059 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 15, 2026, 266 days later.

← All decisions in June 2026