Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)— 510(k) K253059
Substantially EquivalentTournicare Pty, Ltd.
FDA 510(k) clearance K253059 for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08), Substantially Equivalent on 2026-06-15. Applicant: Tournicare Pty, Ltd.. Device class: 2.
Summary
Tournicare's ARMA Automatic Blood Pressure Monitor (ARMA-08) is filed under DXN, non-invasive blood pressure measurement systems. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Tournicare filed from Balwyn, Australia. The decision came 266 calendar days after FDA received it (September 22, 2025 to June 15, 2026).
Clearance details
- Applicant
- Tournicare Pty, Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Balwyn, AU
Recent devices under product code DXN
view all- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.