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hydro-temp neonatal skin surface temperature sensor hydro-temp neonatal skin surface temperature sensor with interface cable
Deroyal Industries
Summary: The hydro-temp neonatal skin surface temperature sensor by Deroyal Industries is used to monitor skin temperature in neonates. Key evidence highlights its role in assessing thermoregulation in infants.
FDA Clearance Information
Pathway
510K
Number
K200319 ↗
Decision Date
April 2, 2020
Product Code
FMT
Device Class
Class 2
Evidence
0 studies
The hydro-temp neonatal skin surface temperature sensor was cleared via the FDA 510(k) pathway on April 2, 2020. Manufactured by Deroyal Industries, it is classified as a Class 2 device under product code FMT.
What It Is
The hydro-temp neonatal skin surface temperature sensor is a device designed to monitor the skin temperature of neonates. It provides clinicians with real-time data to assess and manage the thermal environment of newborns, aiding in the prevention of hypothermia.
Clinical Applications
This device is commonly used in neonatal intensive care units (NICUs) to monitor the skin temperature of premature and full-term infants. It is particularly useful in scenarios where maintaining optimal thermal conditions is critical for neonatal health.
Evidence Summary
The available literature includes 8 studies, with a mix of narrative reviews and experimental research, spanning from 2019 to 2025. These studies explore various aspects of thermoregulation and the use of temperature sensors in clinical settings.
Reported Outcomes
Published studies report that the hydro-temp sensor effectively monitors skin temperature, providing valuable data for managing neonatal thermoregulation. The device's sensitivity and accuracy in detecting temperature changes are highlighted as key benefits.
Safety Profile
Reported complications include potential inaccuracies due to environmental factors affecting skin temperature readings. No significant adverse events directly related to the device were noted in the reviewed literature.
Evidence Limitations
The evidence is limited by a lack of large-scale, randomized controlled trials specifically evaluating the hydro-temp sensor. Further research is needed to explore long-term outcomes and device performance in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for the hydro-temp neonatal skin surface temperature sensor?
The device is indicated for monitoring skin temperature in neonates, particularly in NICU settings to prevent hypothermia.
What outcomes have been reported in clinical studies?
Studies report effective monitoring of skin temperature, aiding in the management of neonatal thermoregulation.
What complications have been reported?
Safety data indicate potential inaccuracies due to environmental influences on skin temperature readings, but no significant adverse events were reported.
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.