Cleared Special

K110776 - DIGITAL THERMOMETER MT SERIES

K110776 is the FDA 510(k) clearance for DIGITAL THERMOMETER MT SERIES by Sejoy Electronics & Instruments Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Special 510(k) pathway after a 156-day FDA review.

K110776 · Sejoy Electronics & Instruments Co., Ltd. · General Hospital
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Aug 2011
Decision
156d
Days
Class 2
Risk

K110776 is an FDA 510(k) clearance for the DIGITAL THERMOMETER MT SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sejoy Electronics & Instruments Co., Ltd. (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on August 24, 2011 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. 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.

View all Sejoy Electronics & Instruments Co., Ltd. devices

Submission Details

510(k) Number K110776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date August 24, 2011
Days to Decision 156 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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
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