Cleared Traditional

K782043 - INDICATOR, BIPOLAR TEMPERATURE

K782043 is an FDA 510(k) clearance for INDICATOR, manufactured by Micronex, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K782043 · Micronex, Inc. · General Hospital
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Jan 1979
Decision
40d
Days
Class 2
Risk

K782043 is an FDA 510(k) clearance for the INDICATOR, BIPOLAR TEMPERATURE. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Micronex, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 40 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 Micronex, Inc. devices

FDA 510(k) Submission Details - K782043

510(k) Number K782043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1978
Decision Date January 17, 1979
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 K782043.
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
THERMOMETER, MODEL 49TA
K781312 · Yellow Springs Instrument Co., Inc. · Aug 1978
PROBE COVER
K780593 · Abco Dealers, Inc. · Jun 1978