Cleared Traditional

K013779 - THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F

K013779 is an FDA 510(k) clearance for THERMOMETER MODELS ST8132C, manufactured by Mesure Technology. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K013779 · Mesure Technology · General Hospital
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Mar 2002
Decision
136d
Days
Class 2
Risk

K013779 is an FDA 510(k) clearance for the THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST85.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mesure Technology (Acton, US). The FDA issued a Cleared decision on March 29, 2002 after a review of 136 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K013779

510(k) Number K013779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date March 29, 2002
Days to Decision 136 days
Submission Type Traditional
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
7d slower than avg
Panel avg: 129d · This submission: 136d
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 681
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K013779.
THERMOMETER MODELS ST8631
K021048 · Z7 International · Apr 2002
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · Global Treasure Industries , Ltd. · Apr 2002
MODEL GT980201 ELECTRONIC THERMOMETER
K021028 · Global Treasure , Ltd. · Apr 2002
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
K020725 · Microlife Corp. · Mar 2002
INFRARED EAR THERMOMETER, MODEL DX-707
K013876 · Jawon Medical Co., Ltd. · Mar 2002
INFRARED EAR THERMOMETER, MODELS TH88 SERIES
K020504 · Radiant Innovation, Inc. · Feb 2002
K013779 · THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
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