Cleared Traditional

Infrared Thermometer (AOJ-20A) (K232128) - FDA 510(k) Clearance

Also marketed or referenced as:
Infrared Thermometer (AOJ-20Y)

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

K232128 · Shenzhen AOJ Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
89d
Days
Class 2
Risk

K232128 is an FDA 510(k) clearance for the Infrared Thermometer (AOJ-20A). 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 October 14, 2023 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen AOJ Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K232128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2023
Decision Date October 14, 2023
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 K232128.
Digital Thermometer, Model T28, T28L
K232678 · Guangdong Genial Technology Co., Ltd. · Jan 2024
Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
K232338 · Alicn Medical (Shenzhen), Inc. · Dec 2023
THERMOCLICK
K222057 · T&R BIOFAB CO., Ltd. · Dec 2023
Reusable Temperature Probe, Disposable Temperature Probe
K223807 · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 2023
Celsi Monitor
K230298 · Hadleigh Health Technologies · Aug 2023
iTEMPSHIELD
K232010 · Aion Biosystems, Inc. · Aug 2023