Cleared Traditional

K791371 - MODEL F-1010 DIGITAL THERMOMETER

K791371 is an FDA 510(k) clearance for MODEL F-1010 DIGITAL THERMOMETER, manufactured by Filac Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K791371 · Filac Corp. · General Hospital
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Sep 1979
Decision
55d
Days
Class 2
Risk

K791371 is an FDA 510(k) clearance for the MODEL F-1010 DIGITAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Filac Corp. (Walker, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 55 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.

View all Filac Corp. devices

FDA 510(k) Submission Details - K791371

510(k) Number K791371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date September 17, 1979
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 129d · This submission: 55d
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 620
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K791371.
IVAC 811Y ELEC. CLINICAL THERMOMETER
K801930 · Y · Sep 1980
ELECTRONIC CLINICAL THERM. MODEL 811A
K800512 · Y · Mar 1980
YSI SERIES 500 THERMISTOR PROBES
K792116 · Yellow Springs Instrument Co., Inc. · Jan 1980
IVAC 833 ELECTRONIC THERMOMETER
K791208 · Y · Aug 1979
IVAC 819 ELECTRONIC THERMOMETER
K791209 · Y · Aug 1979
TEMPERATURE MODULE, DUAL
K781136 · Cavitron Corp. · Aug 1978