Cleared Traditional

K011585 - FAST THERMOMETER MODELS ST713C AND ST713F

K011585 is an FDA 510(k) clearance for FAST THERMOMETER MODELS ST713C AND ST713F, 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 21-day FDA review.

K011585 · Mesure Technology · General Hospital
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Jun 2001
Decision
21d
Days
Class 2
Risk

K011585 is an FDA 510(k) clearance for the FAST THERMOMETER MODELS ST713C AND ST713F. 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 June 13, 2001 after a review of 21 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 - K011585

510(k) Number K011585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2001
Decision Date June 13, 2001
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 K011585.
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
GERATHERM BABYWATCH TEMPERATURE MONITOR
K001281 · Geratherm AG · Jun 2001
TEMP-A-SURE
K010866 · Homecare Technologies , Ltd. · Jun 2001
TEMP SCAN
K010383 · Tenghi Co., Ltd. · Apr 2001
K011585 · FAST THERMOMETER MODELS ST713C AND ST713F
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