Cleared Abbreviated

K212598 - iHealth infrared Ear thermometer PT5 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K212598 · Andon Health Co, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
165d
Days
Class 2
Risk

K212598 is an FDA 510(k) clearance for the iHealth infrared Ear thermometer PT5. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on January 28, 2022 after a review of 165 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Andon Health Co, Ltd. devices

Submission Details

510(k) Number K212598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 128d · This submission: 165d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 796
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K212598.
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
K251160 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2026
Ear Thermometer (EAR-E101)
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K243000 · Shenzhen Medke Technology Co., Ltd. · Jun 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · May 2025
Infrared Thermometer
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AION TempShield™
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