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510(k) K211776

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) by Microlife Intellectual Property GmbH — Product Code FLL

K211776 is an FDA 510(k) premarket notification submitted by Microlife Intellectual Property GmbH for the device "Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)". The FDA issued a decision of Substantially Equivalent on March 1, 2022. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Microlife Intellectual Property GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
June 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Measurement Thermometer
Device Class
Class II
Regulation Number
880.2910
Review Panel
HO
Submission Type

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Other clearances by Microlife Intellectual Property GmbH

  • K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K (June 28, 2023)
  • K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (May 19, 2023)
  • K222153 — Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN20 (February 3, 2023)
  • K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (November 4, 2021)
  • K202729 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (April 8, 2021)
  • K200738 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (July 23, 2020)
  • K200297 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (June 18, 2020)
  • K191829 — Microlife Non-Contact Infrared Forehead Thermometer (February 13, 2020)
  • K183663 — Microlife Digital Infrared Ear Thermometer (July 16, 2019)
  • K190818 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor (July 10, 2019)

Other clearances for product code FLL

  • K253162 — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (June 5, 2026)
  • K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L (January 8, 2026)
  • K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
  • K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature (June 20, 2025)
  • K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
  • K243082 — Infrared Thermometer (April 25, 2025)
  • K250401 — AION TempShield™ (March 14, 2025)
  • K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR2 (February 14, 2025)
  • K240333 — Wearable Digital Thermometer (T31) (October 30, 2024)
  • K240223 — FMT Disposable and Autoclavable Temperature Probes (October 25, 2024)

FDA data resources