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surface temperature probes
Coast Medical
Summary: Surface temperature probes by Coast Medical are used for monitoring temperature in clinical settings. They are FDA-cleared and linked to 14 studies, highlighting their application in various medical scenarios.
FDA Clearance Information
Pathway
510K
Number
K943270 ↗
Decision Date
December 5, 1994
Product Code
FLL
Device Class
Class 2
Evidence
0 studies
The surface temperature probes by Coast Medical were cleared through the FDA 510(k) pathway on December 5, 1994. They are classified as Class 2 devices under product code FLL.
What It Is
Surface temperature probes are medical devices used to measure the temperature of the skin's surface. They are designed for non-invasive temperature monitoring, providing clinicians with critical data for patient management.
Clinical Applications
These probes are commonly used in surgical settings, intensive care units, and during procedures requiring precise temperature monitoring. They are particularly useful in scenarios where non-invasive temperature assessment is preferred.
Evidence Summary
The literature includes 14 studies, comprising various study types such as RCTs and case series, conducted between 2000 and 2018. These studies explore the efficacy and safety of surface temperature probes in clinical practice.
Reported Outcomes
Published studies report that surface temperature probes are effective in providing accurate temperature readings comparable to invasive methods. They are particularly noted for their utility in monitoring during surgical procedures and critical care settings.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a high safety profile for non-invasive temperature monitoring. No significant safety concerns were highlighted in the reviewed literature.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and comparative effectiveness with other temperature monitoring devices.
Frequently Asked Questions
What are the clinical indications for surface temperature probes?
Surface temperature probes are indicated for non-invasive temperature monitoring in various clinical settings, including surgery and intensive care.
What outcomes have been reported in clinical studies?
Studies report that surface temperature probes provide accurate and reliable temperature readings, comparable to invasive methods.
What complications have been reported?
Reported complications include minimal adverse events, with a high safety profile noted in the literature.
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.