Cleared Traditional

K200531 - iHealth Infrared No-Touch Forehead Thermometer

K200531 is an FDA 510(k) clearance for iHealth Infrared No-Touch Forehead Ther..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K200531 · Andon Health Co, Ltd. · General Hospital
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Jul 2020
Decision
135d
Days
Class 2
Risk

K200531 is an FDA 510(k) clearance for the iHealth Infrared No-Touch Forehead Thermometer. 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 July 15, 2020 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Andon Health Co, Ltd. devices

FDA 510(k) Submission Details - K200531

510(k) Number K200531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date July 15, 2020
Days to Decision 135 days
Submission Type Traditional
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
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

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 527
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K200531.
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 2020
Disposable Temperature Probe
K193625 · Shenzhen Changke Connect Electronics Co., Ltd. · Jul 2020
Infrared Thermometer Model Number RN-50A,RN-50B
K200578 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Jul 2020
Digital Thermometer
K200599 · Joytech Healthcare Co. , Ltd. · Jul 2020
Infrared Thermometer Model Number RN-60A,RN-60B
K200471 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Jun 2020
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503
K193253 · Shenzhen Changkun Technology Co., Ltd. · Jun 2020