Cleared Traditional

K831718 - ELECTRONIC CLINICAL THERMOMETER

K831718 is an FDA 510(k) clearance for ELECTRONIC CLINICAL THERMOMETER, manufactured by Mitteloy. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K831718 · Mitteloy · General Hospital
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Jul 1983
Decision
42d
Days
Class 2
Risk

K831718 is an FDA 510(k) clearance for the ELECTRONIC CLINICAL THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mitteloy (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 42 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 Mitteloy devices

FDA 510(k) Submission Details - K831718

510(k) Number K831718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1983
Decision Date July 12, 1983
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 613
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K831718.
RECTAL TEMP. TELEMETRY MONITOR
K832404 · Xomed, Inc. · Sep 1983
TEMPERATURE MODULE 242-100
K831733 · Kontron Instruments, Inc. · Aug 1983
LME TEMP. MONITOR
K832042 · Litton Medical Electronics · Aug 1983
DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE
K830592 · Electromedics, Inc. · May 1983
TEMP TRACE
K830530 · Progress Mankind Technology · Apr 1983
MODIFICATION ELECTRONIC CLINICAL THERMO-
K830819 · Mon-A-Therm, Inc. · Apr 1983