Cleared Traditional

K063542 - WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.

K063542 is an FDA 510(k) clearance for WIRELESS TEMPERATURE MONITOR / MODELS S..., manufactured by Mesure Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K063542 · Mesure Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
137d
Days
Class 2
Risk

K063542 is an FDA 510(k) clearance for the WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mesure Technology Co., Ltd. (San Chung City, TW). The FDA issued a Cleared decision on April 10, 2007 after a review of 137 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 - K063542

510(k) Number K063542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2006
Decision Date April 10, 2007
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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 695
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K063542.
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)
K062784 · Sejoy Electronics & Instruments Co., Ltd. · May 2007
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
K071019 · Mesure Technology Co., Ltd. · Apr 2007
RII INFRARED EAR THERMOMETER, MODEL TH01BN
K070976 · Radiant Innovation, Inc. · Apr 2007
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
K070342 · American I.V. Products, Inc. · Mar 2007
MONITORING EAR THERMOMETER, MODEL BTM-D1A
K062445 · Rio Flexon Technology Co., Ltd. · Feb 2007
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
K070028 · Actherm, Inc. · Feb 2007
K063542 · WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
Download PDF FDA Summary Mesure Technology Co.…