Cleared Special

K100226 - WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

K100226 is an FDA 510(k) clearance for WIRELESS BODY TEMPERATURE MONITOR MODEL..., manufactured by Rio Flexon Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 52-day FDA review.

K100226 · Rio Flexon Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
52d
Days
Class 2
Risk

K100226 is an FDA 510(k) clearance for the WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Rio Flexon Technology Co., Ltd. (Jhonghe City Taipei County, TW). The FDA issued a Cleared decision on March 18, 2010 after a review of 52 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K100226

510(k) Number K100226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2010
Decision Date March 18, 2010
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 Peers - FLL Continuous Measurement Thermometer

All 697
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K100226.
NON-INVASIVE INFRARED (NIR)
K090386 · Medisim, Ltd. · May 2010
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K100942 · Taidoc Technology Corporation · May 2010
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
K100953 · Microlife Intellectual Property GmbH · May 2010
ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010
K093795 · Actherm, Inc. · Mar 2010
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
K100016 · Avita Corporation · Mar 2010
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
K092447 · Hangzhou Hua'An Medical & Health Instruments Co., · Jan 2010
K100226 · WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)
Download PDF FDA Summary Rio Flexon Technology…