Cleared Traditional

K181239 - Infrared Forehead Thermometer

K181239 is the FDA 510(k) clearance for Infrared Forehead Thermometer by Joytech Healthcare Co. , Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K181239 · Joytech Healthcare Co. , Ltd. · General Hospital
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Oct 2018
Decision
172d
Days
Class 2
Risk

K181239 is an FDA 510(k) clearance for the Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 29, 2018 after a review of 172 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 Joytech Healthcare Co. , Ltd. devices

Submission Details

510(k) Number K181239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2018
Decision Date October 29, 2018
Days to Decision 172 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
43d slower than avg
Panel avg: 129d · This submission: 172d
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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K181239.
Infrared Thermometer
K182133 · Shenzhen AOJ Medical Technology Co., Ltd. · Nov 2018
COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
K182652 · Kangfu Medical Equipment Factory · Nov 2018
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K180047 · Fiab Spa · Nov 2018
Swaive Thermometer SWT1A
K170723 · E-Care Technology Co., Ltd. · Oct 2018
TD-1035 Thermometer
K172733 · Taidoc Technology Corporation · Oct 2018
Temperature Probe
K173194 · Orantech, Inc. · Oct 2018