Cleared Traditional

K140681 - BELTER INFRA-RED EAR THERMOMETER

K140681 is an FDA 510(k) clearance for BELTER INFRA-RED EAR THERMOMETER, manufactured by Shenzhen Belter Health Measurement and Analysis TE. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K140681 · Shenzhen Belter Health Measurement and Analysis TE · General Hospital
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Aug 2014
Decision
156d
Days
Class 2
Risk

K140681 is an FDA 510(k) clearance for the BELTER INFRA-RED EAR THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shenzhen Belter Health Measurement and Analysis TE (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on August 21, 2014 after a review of 156 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 Shenzhen Belter Health Measurement and Analysis TE devices

FDA 510(k) Submission Details - K140681

510(k) Number K140681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date August 21, 2014
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FLL Continuous Measurement Thermometer

All 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K140681.
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