Cleared Abbreviated

iHealth infrared Ear thermometer PT5

K212598 · Andon Health Co, Ltd. · General Hospital
Jan 2022
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K212598 is an FDA 510(k) clearance for the iHealth infrared Ear thermometer PT5, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on January 28, 2022, 165 days after receiving the submission on August 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number K212598 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2021
Decision Date January 28, 2022
Days to Decision 165 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLL — Continuous Measurement Thermometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2910
Definition 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.

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