Cleared Special

K020725 - MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1

K020725 is an FDA 510(k) clearance for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, manufactured by Microlife Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 6-day FDA review.

K020725 · Microlife Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
6d
Days
Class 2
Risk

K020725 is an FDA 510(k) clearance for the MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Microlife Corp. (Great Neck, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 6 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020725

510(k) Number K020725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date March 12, 2002
Days to Decision 6 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 129d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

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 668
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K020725.
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · Global Treasure Industries , Ltd. · Apr 2002
MODEL GT980201 ELECTRONIC THERMOMETER
K021028 · Global Treasure , Ltd. · Apr 2002
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
K013779 · Mesure Technology · Mar 2002
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K013876 · Jawon Medical Co., Ltd. · Mar 2002
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K020504 · Radiant Innovation, Inc. · Feb 2002
INFARED EAR THERMOMETER, MODEL TH8 SERIES
K011059 · Radiant Innovation, Inc. · Sep 2001