Cleared Traditional

K102718 - DIGITAL THERMOMETER

Also marketed or referenced as:
DIGITAL THERMOMETER

K102718 is an FDA 510(k) clearance for DIGITAL THERMOMETER, manufactured by International Regulatory Consultants, LLC (Irc). The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K102718 · International Regulatory Consultants, LLC (Irc) · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
83d
Days
Class 2
Risk

K102718 is an FDA 510(k) clearance for the DIGITAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by International Regulatory Consultants, LLC (Irc) (Taichung, CN). The FDA issued a Cleared decision on December 13, 2010 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K102718

510(k) Number K102718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2010
Decision Date December 13, 2010
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 K102718.
INFRARED EAR THERMOMETER, MODEL IR-04MT
K102934 · Vega Technologies, Inc. · Jan 2011
YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
K102508 · Yu Long Sheng Technology Co., Ltd. · Jan 2011
INFRARED EAR THERMOMETER
K103097 · Radiant Innovation, Inc. · Dec 2010
RII INFRARED EAR THERMOMETER,
K102187 · Radiant Innovation, Inc. · Dec 2010
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
K101244 · Truer Medical, Inc. · Nov 2010
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
K101912 · Hubdic Co., Ltd. · Nov 2010
K102718 · DIGITAL THERMOMETER
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