Cleared Traditional

Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y (K221039) - FDA 510(k) Clearance

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

K221039 · Shenzhen AOJ Medical Technology Co., Ltd. · General Hospital
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Dec 2022
Decision
257d
Days
Class 2
Risk

K221039 is an FDA 510(k) clearance for the Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen AOJ Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 20, 2022 after a review of 257 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 Shenzhen AOJ Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K221039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2022
Decision Date December 20, 2022
Days to Decision 257 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
128d slower than avg
Panel avg: 129d · This submission: 257d
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 Peers - FLL Continuous Measurement Thermometer

All 214
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K221039.
Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
K222588 · Iweecare Co., Ltd. · Feb 2023
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
K220657 · Zhejiang Rongsheng Industrial Co., Ltd. · Feb 2023
Digital Thermometer, Model: DT007, DT008
K214077 · Guangzhou Berrcom Medical Device Co., Ltd. · Jan 2023
Infrared Thermometer (Model: Y20001, Y20002)
K221800 · Zhangzhou Easepal Medical Science and Technology Co., Ltd. · Dec 2022
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
K211050 · Jkh Health Co., Ltd. · Nov 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
K221170 · Shenzhen AOJ Medical Technology Co., Ltd. · Oct 2022