Cardio Metrics Invasive Pressure Monit

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

510(k) Number

K841960 ↗

FDA Product Code

DRS

Device Class

Class II

Regulation

21 CFR Part 870.2850

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Custom Sterile Procedure Kits

  Not classified

  FDA 510(k) K842356 Active Cleared 21 Mar 1985

• Sterile Design-Custom Sterile IV Kit

  Class II

  FDA 510(k) K842351 Active Cleared 15 Oct 1984

• Cardio Metric Custom Perfusion Tubing

  Class II

  FDA 510(k) K841959 Active Cleared 19 Oct 1984

• Pan Set

  Class II

  FDA 510(k) K813437 Active Cleared 31 Dec 1981

• Custom Dressing Change Trays

  Class I

  FDA 510(k) K791738 Active Cleared 2 Oct 1979

• Cardio Metrics Cardiotomy Reservoir

  Class II

  FDA 510(k) K841958 Active Cleared 15 Oct 1984

See all devices from Sterile Design, Inc. →

• What clinical scenarios is the Cardio Metrics Invasive Pressure Monitor primarily used for?

  The Cardio Metrics Invasive Pressure Monitor is designed to measure and monitor intravascular pressure in real-time, making it ideal for critical cardiovascular assessments. This includes settings like intensive care units (ICUs), operating rooms, and emergency departments where precise hemodynamic monitoring—such as arterial, venous, or central venous pressure—is essential for patient stability, fluid management, and treatment decisions.

• Is the device intended for reuse, or is it strictly single-use? How should it be handled to maintain sterility?

  The device is explicitly designed for single-use only to ensure patient safety and sterility. It is supplied sterile, so it must be handled with sterile technique—using gloves, avoiding contamination, and adhering to manufacturer guidelines for unpacking and connection to monitoring systems. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?

  The Cardio Metrics Invasive Pressure Monitor received FDA clearance under a 510(k) submission, classified as Substantially Equivalent (SESE) to a predicate device. The clearance was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and falls under Regulation 870.2850, which governs blood-pressure transducers. The decision was finalized in 1985, confirming its compliance with FDA standards for Class II medical devices.

• Are there multiple sizes or models available for this device? If so, how would a clinician determine the correct fit?

  While the provided data does not specify exact sizes or model variants (e.g., pediatric vs. adult), the device is categorized under product code DRS and is designed for general intravascular pressure monitoring. Clinicians should refer to the manufacturer’s instructions for compatibility with specific catheters or monitoring systems, ensuring proper calibration and connection to avoid measurement errors. If multiple models exist, they would likely be differentiated by connector types or pressure range suitability.

• What storage conditions are required to preserve the device’s integrity before use?

  Since the device is sterile and single-use, it must be stored in its original, unopened packaging to prevent contamination. The manufacturer’s guidelines (not detailed here) would specify environmental conditions like temperature and humidity, but generally, it should be kept in a clean, dry area away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or sterility indicators before use.