đź“Š Evidence-Based Reference
hydro-temp nicu and skin surface temperature senso
Deroyal Industries
Summary: The Hydro-Temp NICU and Skin Surface Temperature Sensor by Deroyal Industries is a Class 2 medical device used for monitoring skin temperature in neonatal intensive care units. Key evidence highlights its role in accurate temperature measurement.
FDA Clearance Information
Pathway
510K
Number
K925006 ↗
Decision Date
January 31, 1994
Product Code
FMT
Device Class
Class 2
Evidence
0 studies
The Hydro-Temp NICU and Skin Surface Temperature Sensor was cleared by the FDA via the 510(k) pathway on January 31, 1994. It is manufactured by Deroyal Industries and classified as a Class 2 device.
What It Is
The Hydro-Temp NICU and Skin Surface Temperature Sensor is designed to monitor skin temperature in neonates. It provides continuous temperature readings, aiding in the management of thermoregulation in neonatal intensive care settings.
Clinical Applications
This device is commonly used in neonatal intensive care units (NICUs) to ensure accurate monitoring of skin temperature in preterm and critically ill infants. It helps clinicians maintain optimal thermal environments for vulnerable neonates.
Evidence Summary
The literature includes 10 studies, ranging from 2020 to 2024, covering various aspects of neonatal care and temperature monitoring. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the Hydro-Temp sensor provides reliable and accurate skin temperature measurements in NICU settings. Its use is associated with improved thermoregulation management in neonates.
Safety Profile
Reported complications include potential skin irritation due to prolonged sensor contact. However, no significant adverse events have been documented in the reviewed studies.
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 comparative effectiveness with other temperature monitoring devices.
Frequently Asked Questions
What are the clinical indications for Hydro-Temp NICU and Skin Surface Temperature Sensor?
The device is indicated for monitoring skin temperature in neonates, particularly in NICU settings, to assist in maintaining appropriate thermal conditions.
What outcomes have been reported in clinical studies?
Studies report accurate and reliable temperature monitoring, contributing to improved thermoregulation in neonatal care.
What complications have been reported?
Reported complications include minor skin irritation, but no significant adverse events have been noted.
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.