Electromedics Blood Heat Exchanger

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

510(k) Number

K934355 ↗

FDA Product Code

DTR

Device Class

Class II

Regulation

21 CFR Part 870.4240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Tcpm II Tourniquet Cuff Pressure Monitor

  Class I

  FDA 510(k) K900104 Active Cleared 15 Mar 1990

• Electromedics BT422-120 and BT422-40

  Class II

  FDA 510(k) K903392 Active Cleared 6 Sep 1990

• EL2-Series Blood Collection Reervoir

  Class II

  FDA 510(k) K930154 Active Cleared 1 Jul 1993

• Bt 794-Blood/Fluid Warmer

  Class II

  FDA 510(k) K822098 Active Cleared 20 Aug 1982

• Bt-795/P Automated Autotrans

  Class II

  FDA 510(k) K860306 Active Cleared 6 Mar 1986

• Dispos. Type T Thermocouple Temp.probe

  Class II

  FDA 510(k) K830592 Active Cleared 18 May 1983

See all devices from Electromedics, Inc. →

• What is the Electromedics Blood Heat Exchanger used for?

  The Electromedics Blood Heat Exchanger is designed as part of an extracorporeal circulation system to regulate blood temperature during cardiopulmonary bypass (CPB) procedures. It ensures precise warming or cooling of blood or perfusion fluid, which is critical for maintaining stable hemodynamic parameters during open-heart surgeries and other cardiac interventions. This helps surgeons control core temperature, reducing risks like hypothermia or hyperthermia.

• Is the Electromedics Blood Heat Exchanger intended for single-use or reuse?

  The Electromedics Blood Heat Exchanger is explicitly supplied as a single-use component. This design choice aligns with sterile surgical environments, where contamination risks must be minimized. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

• What regulatory pathway does this device follow?

  The Electromedics Blood Heat Exchanger is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K934355). It falls under the Heat-Exchanger, Cardiopulmonary Bypass (DTR) category (FDA regulation number 870.4240), with a substantially equivalent determination by the FDA’s Cardiovascular (CV) advisory committee. This clearance confirms its compliance with safety and performance standards for use in temperature control during CPB.

• How is the device supplied, and where should it be stored?

  The device is supplied as a sterile, single-use component for immediate surgical use. It should be stored in its original packaging in a clean, dry environment, protected from physical damage and contamination. Avoid exposure to extreme temperatures or direct sunlight, as these could degrade performance. Always check expiration dates and ensure the packaging remains intact before use.

• Are there any known limitations or special considerations for this device?

  While the Electromedics Blood Heat Exchanger is designed for precise temperature control, its specific technical specifications (e.g., dimensions, flow rates, or material compatibility) are not detailed in available data. Clinicians should verify compatibility with their existing CPB systems and follow manufacturer guidelines for integration. Additionally, no MRI safety information is provided, so it should not be used in MRI environments unless confirmed safe by the manufacturer.