Cleared Traditional

Non-contact Electronic Forehead Infrared Thermometer (K201582) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201582 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · General Hospital
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Jan 2021
Decision
218d
Days
Class 2
Risk

K201582 is an FDA 510(k) clearance for the Non-contact Electronic Forehead Infrared Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on January 15, 2021 after a review of 218 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 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 Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. devices

Submission Details

510(k) Number K201582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date January 15, 2021
Days to Decision 218 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
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Yoyo Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K201582.
Non-Contact Forehead Thermometer (Models UT306H & UT308H)
K203747 · Uni-Trend Technology (China) Co., Ltd. · Jan 2021
Non-Contact Forehead Thermometer (UT30H)
K203656 · Uni-Trend Technology (China) Co., Ltd. · Jan 2021
Infrared Thermometer
K201579 · Shenzhen Xunwei Industrial Co., Ltd. · Jan 2021
Non-contact Infrared Body Thermometer, model:HTD8823US
K200159 · Hetaida Technology Co., Ltd. · Jan 2021
iHealth Clinical Digital Thermometer
K202791 · Andon Health Co, Ltd. · Jan 2021
DeRoyal Temperature Monitoring Probe
K200631 · Deroyal Industries, Inc. · Dec 2020