Cleared Traditional

K182652 - COCET Digital Thermometer (Models KFT-0...

K182652 is the FDA 510(k) clearance for COCET Digital Thermometer (Models KFT-0... by Kangfu Medical Equipment Factory. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K182652 · Kangfu Medical Equipment Factory · General Hospital
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Nov 2018
Decision
57d
Days
Class 2
Risk

K182652 is an FDA 510(k) clearance for the COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/K.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kangfu Medical Equipment Factory (Yueqing City, CN). The FDA issued a Cleared decision on November 20, 2018 after a review of 57 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 Kangfu Medical Equipment Factory devices

Submission Details

510(k) Number K182652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date November 20, 2018
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 K182652.
welloStationX
K180298 · Wello, Inc. · Nov 2018
Non-contact Infrared Thermometer
K180207 · Alicn Medical (Shenzhen), Inc. · Nov 2018
Infrared Thermometer
K182133 · Shenzhen AOJ Medical Technology Co., Ltd. · Nov 2018
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
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Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · Joytech Healthcare Co. , Ltd. · Oct 2018
Swaive Thermometer SWT1A
K170723 · E-Care Technology Co., Ltd. · Oct 2018