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Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)

by Microlife Intellectual Property GmbH 510(k)

Active United States

510(k) K211776

Overview

The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is a device intended for the intermittent measurement and monitoring of human body temperature. It uses infrared technology to measure temperature without physical contact with the skin.

This device is supplied as a non-sterile, reusable thermometer for use in general hospital and home settings. It has received FDA 510(k) clearance under product code FLL and decision code SESE, with a decision date of March 1, 2022, and is manufactured by Microlife Intellectual Property GmbH in Widnau, Switzerland.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211776 Date1 Mar 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Microlife FR1MF1-B (NC150 BT) thermometer used for?

    It is intended for the intermittent measurement and monitoring of human body temperature using infrared technology without skin contact, suitable for general hospital and home use as stated in the device description.

  • Is the Microlife FR1MF1-B (NC150 BT) thermometer sterile or non-sterile, and is it reusable?

    The device is supplied as a non-sterile, reusable thermometer, meaning it is not provided in a sterile condition and can be used multiple times following appropriate cleaning procedures for general hospital and home environments.

  • What regulatory clearance does the Microlife FR1MF1-B (NC150 BT) have and when was it granted?

    It received FDA 510(k) clearance under product code FLL and decision code SESE, with a decision date of March 1, 2022, indicating it was found substantially equivalent to a legally marketed predicate device.