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HYDRO-TEMP Neonatal Skin Surface Temperature Sensor

by Deroyal Industries, Inc.

510(k) K200319

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200319↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK200319 Date2 Apr 2020ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
510(k) Number
FDA Product Code
FMT
Device Class
Class II
Regulation
21 CFR Part 880.5130
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hydro-Temp Neonatal Skin Surface Temperature Sensor is a medical device classified as an infant radiant warmer accessory, designed to monitor and measure the skin surface temperature of neonates. It provides precise thermal data to support neonatal care and stability in clinical settings.

This device is supplied as a reusable sensor, intended for use in general hospital environments. It is authorized under FDA 510K clearance, MDD, and MDR regulations, with a device classification of Class II. The sensor may be paired with an interface cable for connectivity and is regulated under the FDA’s 880.5130 product code for infant radiant warmers.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Hydro-Temp Neonatal Skin Surface Temperature Sensor designed for single-use or reusable in clinical settings?

    The Hydro-Temp Neonatal Skin Surface Temperature Sensor is explicitly described as a reusable device, intended for use in general hospital environments. This classification aligns with its regulatory submission under the FDA’s 510(k) pathway and its classification as a Class II medical device, which often includes reusable accessories for infant radiant warmers.

  • What types of connectivity options are available for this temperature sensor, and how does that affect its use?

    The Hydro-Temp Neonatal Skin Surface Temperature Sensor can be used with or without an interface cable, depending on the model. The version paired with an interface cable allows for direct connectivity to monitoring systems, ensuring seamless integration with neonatal care equipment. This flexibility supports various clinical workflows where real-time thermal data is critical for infant stability.

  • How is the regulatory approval status of this device categorized, and what does that imply for its use in hospitals?

    The Hydro-Temp Neonatal Skin Surface Temperature Sensor holds FDA 510(k) clearance, as well as compliance under the MDD (Medical Device Directive) and MDR (Medical Device Regulation). Its classification as a Class II device under FDA regulations indicates it has undergone rigorous review for safety and performance, ensuring it meets standards for use in general hospital settings as an accessory to infant radiant warmers.

  • What clinical environment is this sensor primarily intended for, and why is that important for buyers?

    This sensor is explicitly designed for general hospital environments, particularly as an accessory for infant radiant warmers. Its regulatory submission under the FDA’s 880.5130 product code and advisory committee classification for General Hospital settings confirms its suitability for neonatal care units where precise temperature monitoring is essential. Buyers should prioritize this device if their facility requires reusable, hospital-grade thermal monitoring for newborns.

  • Are there multiple models or variations of this sensor, and if so, how do they differ in functionality?

    Yes, there are two listed variations: the standalone Hydro-Temp Neonatal Skin Surface Temperature Sensor and the same sensor with an interface cable. The key difference lies in connectivity—the cable-equipped version enables direct data transmission to monitoring systems, while the standalone version may require additional adapters or manual reading. This distinction allows clinicians to choose based on their facility’s infrastructure and workflow needs.