Cleared Traditional

K011254 - EAR THERMOMETER, MODELS ST613C AND ST613F

K011254 is an FDA 510(k) clearance for EAR THERMOMETER, 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 77-day FDA review.

K011254 · Mesure Technology · General Hospital
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Jul 2001
Decision
77d
Days
Class 2
Risk

K011254 is an FDA 510(k) clearance for the EAR THERMOMETER, MODELS ST613C AND ST613F. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mesure Technology (Mission Viejo, US). The FDA issued a Cleared decision on July 10, 2001 after a review of 77 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 - K011254

510(k) Number K011254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2001
Decision Date July 10, 2001
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 K011254.
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · Avita Corporation · Sep 2001
M5T INSTANT FEVER THERMOMETER
K012217 · Medisim, Ltd. · Aug 2001
TEMPORALSCANNER THERMOMETER, SENSORTOUCH
K011291 · Exergen Corp. · Jul 2001
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
K010235 · Oriental System Technology, Inc. · Jul 2001
NPAC EAR THERMOMETER MODEL TD 402
K011704 · Norm Pacific Automation Corp. · Jun 2001
YOUNG-HEALTH SUPER EAR THERMOMETER
K002727 · Young Health Ind. Co., Ltd. · Jun 2001
K011254 · EAR THERMOMETER, MODELS ST613C AND ST613F
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