Cleared Traditional

K153146 - Infrared Ear Thermometer

K153146 is the FDA 510(k) clearance for Infrared Ear Thermometer by Sejoy Electronics & Instruments Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K153146 · Sejoy Electronics & Instruments Co., Ltd. · General Hospital
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Mar 2016
Decision
153d
Days
Class 2
Risk

K153146 is an FDA 510(k) clearance for the Infrared Ear Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sejoy Electronics & Instruments Co., Ltd. (Hang Zhou, CN). The FDA issued a Cleared decision on March 31, 2016 after a review of 153 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 Sejoy Electronics & Instruments Co., Ltd. devices

Submission Details

510(k) Number K153146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date March 31, 2016
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K153146.
Microlife Digital Infrared Ear Thermometer
K170219 · Microlife Intellectual Property GmbH · Jul 2017
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
TD-1035 Thermometer
K152680 · Taidoc Technology Corporation · May 2016
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013
DIGITAL THERMOMTER
K122520 · Taidoc Technology Corporation · Feb 2013
FORA COMFORTSCAN EAR THERMOMETER
K120712 · Taidoc Technology Corporation · Jun 2012