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Infrared Thermometer RN-50A, RN-50B

by Ningbo Ranor Medical Science & Technology Co., Ltd.

510(k) K200578

Active European Union and United States

CE MDR 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) K200578↗

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 NumberK200578 Date16 Jul 2020ClearedStatusActive
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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Infrared Thermometer Model Number RN-50A, RN-50B
510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
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 Infrared Thermometer RN-50A and RN-50B are non-contact, infrared devices designed to measure body temperature by detecting thermal radiation emitted from the skin. These thermometers are classified under the product code FLL and are intended for use in general hospital settings, providing rapid and contactless temperature assessment without physical contact with the patient.

These devices are supplied as single-use or reusable (depending on model) and are regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). The RN-50A and RN-50B are intended for use in clinical environments, with no specific MRI safety classification mentioned. Storage conditions are not detailed, but standard medical device hygiene practices should be followed. Both models are authorized for distribution in the United States and the European Union.

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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.

  • Are these infrared thermometers designed for single-use or reusable applications, and how does that affect their use in clinical settings?

    The RN-50A and RN-50B models are supplied as either single-use or reusable, depending on the specific model. The RN-50A is designed for single-use, ensuring hygiene and reducing cross-contamination risk in clinical environments. The RN-50B, on the other hand, is intended for reusable applications, allowing for repeated use after proper cleaning and sterilization as per standard medical device hygiene practices. This distinction is important for facilities prioritizing either convenience (single-use) or cost efficiency (reusable).

  • What types of clinical environments are these thermometers intended for, and how does that influence their use?

    These thermometers are specifically classified under product code FLL and are intended for use in general hospital settings, as indicated by their submission to the General Hospital (HO) advisory committee. This means they are designed for routine temperature assessments in hospitals, clinics, or other healthcare facilities where rapid, non-contact temperature measurement is needed. Their use is not limited to specialized care areas like MRI suites, as no MRI safety classification is mentioned.

  • How should I store these thermometers to maintain their accuracy and functionality over time?

    While the device specifications do not explicitly detail storage conditions, standard medical device hygiene practices should be followed to ensure optimal performance. This includes storing the thermometers in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. For reusable models (e.g., RN-50B), adherence to manufacturer guidelines for cleaning and sterilization is critical to prevent degradation and ensure accurate readings.

  • What regulatory pathways have these thermometers undergone, and where are they authorized for distribution?

    The RN-50A and RN-50B have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR), confirming their authorization for distribution in the United States and the European Union. The FDA submission was classified as substantially equivalent (SESE) under the General Hospital advisory committee, indicating their alignment with existing standards for non-contact infrared thermometers in clinical use.

  • What distinguishes the RN-50A from the RN-50B in terms of usage and practical application?

    The primary distinction lies in their disposable vs. reusable design. The RN-50A is intended for single-use, making it ideal for settings where infection control is paramount, such as during outbreaks or in high-turnover environments like emergency rooms. The RN-50B, however, is designed for reusable applications, allowing for repeated use after proper cleaning and sterilization, which can be cost-effective for facilities with lower infection risks or established reprocessing protocols. Both models share the same core function of rapid, non-contact temperature measurement.