Cleared Special

K152640 - Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)

K152640 is an FDA 510(k) clearance for Infrared Thermometer (FT-F11-BT, manufactured by Fudakang Industries Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 195-day FDA review.

K152640 · Fudakang Industries Co., Ltd. · General Hospital
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Mar 2016
Decision
195d
Days
Class 2
Risk

K152640 is an FDA 510(k) clearance for the Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Fudakang Industries Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on March 28, 2016 after a review of 195 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K152640

510(k) Number K152640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date March 28, 2016
Days to Decision 195 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Modification to existing cleared device.

FLL Device Classification - Class 2, Special Controls

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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
FIELD FU

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 663
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K152640.
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