📋 FDA Reference
Radiant Medical Endocatheter Temperature Probe
Radiant Medical
Summary: The Radiant Medical Endocatheter Temperature Probe is a device used to monitor and regulate body temperature in clinical settings. It is typically used by healthcare professionals in critical care and surgical environments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K042388 ↗
Decision Date ?
October 28, 2004
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Radiant Medical Endocatheter Temperature Probe was cleared through the FDA 510k pathway on October 28, 2004. Manufactured by Radiant Medical, it is classified as a Class 2 medical device.
What It Is
The Radiant Medical Endocatheter Temperature Probe is a specialized device designed to measure and control the temperature of patients undergoing medical procedures. It is inserted into the venous system, allowing for precise temperature monitoring and management. This device is particularly useful in maintaining normothermia during surgeries and in critical care settings.
FDA-Cleared Indications
- Percutaneous catheter intended for intravascular temperature measurement.
- Use in patients who require continuous internal temperature monitoring during medical or surgical care.
Clinical Applications
- Continuous intravascular temperature monitoring during surgery.
- Temperature monitoring in intensive care and other settings requiring ongoing internal measurement.
- Monitoring core temperature in patients undergoing procedures where external temperature measurements may be less reliable.
Practical Considerations
- The catheter must be inserted using appropriate sterile technique and connected to a compatible patient-monitoring system.
- Available size and length options, connector requirements, and operating instructions should be confirmed in the product labeling.
- Because the device is intravascular, clinicians should assess bleeding, infection, thrombosis, vessel injury, and other catheter-related risks before use.
- MRI compatibility should not be assumed. Confirm the exact device labeling and MRI conditions before scanning.
- The probe measures temperature; it should not be described as an intravascular system that actively heats or cools the patient unless the specific product labeling states otherwise.
Procedures that use this device
Frequently Asked Questions
What is the Radiant Medical Endocatheter Temperature Probe used for?
It is used for continuous monitoring and regulation of body temperature in patients undergoing surgery or in critical care settings.
What specialties typically use this device?
Anesthesiology, critical care, and surgical specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring continuous temperature monitoring and management, especially during surgeries or in critical care.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.