Pressure Transducer Dome 1295C

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841613 ↗

FDA Product Code

DRS

Device Class

Class II

Regulation

21 CFR Part 870.2850

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Pressure Transducer Dome 1295C used for?

  The Pressure Transducer Dome 1295C is designed to measure pressure within cardiovascular systems, converting physical pressure into an electrical signal. This allows clinicians to monitor and assess hemodynamic parameters—such as blood flow, pressure, and volume—critical in critical care settings like intensive care units (ICUs) or operating rooms. Its extravascular design enables placement outside blood vessels, providing stable readings for continuous monitoring.

• Is the Pressure Transducer Dome 1295C single-use or reusable?

  The Pressure Transducer Dome 1295C is supplied as a reusable medical instrument. Unlike single-use devices, this model is intended for repeated use after proper sterilization and maintenance, as outlined by the manufacturer. Reusability helps reduce waste and costs while ensuring consistent performance when adhering to cleaning and sterilization protocols.

• What sterilization methods are recommended for the Pressure Transducer Dome 1295C?

  The manufacturer specifies sterilization and maintenance protocols for the Pressure Transducer Dome 1295C, though exact methods are not detailed in the provided data. Typically, reusable medical devices like this require thorough cleaning to remove bioburden followed by sterilization using validated methods such as autoclaving, ethylene oxide gas, or chemical sterilization. Always follow the manufacturer’s instructions to ensure safety and functionality.

• How is the Pressure Transducer Dome 1295C regulated by the FDA?

  The Pressure Transducer Dome 1295C is classified as a Class II medical device under FDA regulations and holds a 510(k) clearance (K841613) with a decision of 'Substantially Equivalent.' This classification and clearance indicate that the device meets FDA standards for safety and effectiveness, with the submission reviewed by the Cardiovascular (CV) Advisory Committee. The device adheres to FDA regulation 870.2850, which governs blood-pressure transducers.

• What are the key specifications or features of the Pressure Transducer Dome 1295C?

  While the provided data does not specify exact technical specifications like frequency response, sensitivity, or pressure range, the Pressure Transducer Dome 1295C is designed for cardiovascular applications to measure extravascular blood pressure. Its dome-shaped design likely enhances stability and accuracy during monitoring. For precise operational details—such as calibration requirements or compatibility with monitoring systems—refer to the manufacturer’s technical documentation or user manual.