Telepress III Blood Pressure Monitor, Model TPIII

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K011058 ↗

FDA Product Code

DXN

FDA applicant

Meridian Medical Technologies , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What clinical measurements does the Telepress III Blood Pressure Monitor provide, and how does it achieve these readings?

  The Telepress III Blood Pressure Monitor measures systolic, diastolic, and mean arterial pressure. It uses transducers placed on the skin’s surface to capture and analyze blood pressure signals, allowing for noninvasive clinical assessment without direct vascular access.

• Is the Telepress III Blood Pressure Monitor intended for single-use or reusable applications in clinical settings?

  The device is explicitly described as a reusable medical instrument, meaning it is designed for repeated use in clinical environments like hospitals or physician offices after proper cleaning and maintenance.

• What regulatory pathway did the Telepress III Blood Pressure Monitor follow to gain market authorization in the U.S.?

  The device received FDA 510(k) clearance under product code DXN, classified as *Substantially Equivalent* to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee and followed a traditional clearance process, with no third-party involvement.

• Does the Telepress III Blood Pressure Monitor come with any specific sterility guarantees or MRI safety information?

  The available data does not mention sterility guarantees or MRI safety for the Telepress III. Users should follow standard infection control protocols for reusable devices and verify MRI compatibility with their facility’s imaging systems if needed.