Cleared Special

K003308 - MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1

K003308 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 22-day FDA review.

K003308 · Microlife Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
22d
Days
Class 2
Risk

K003308 is an FDA 510(k) clearance for the MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1. 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 November 14, 2000 after a review of 22 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 - K003308

510(k) Number K003308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2000
Decision Date November 14, 2000
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 K003308.
GEON DIGITAL CLINICAL THERMOMETER
K003223 · Geon Corp. · Jan 2001
FILAC FAS TEMP ELECTRONIC THERMOMETER
K003313 · The Kendall Company · Jan 2001
AVITA TSO/TS1 INFRARED EAR THERMOMETER
K002182 · Avita Corporation · Dec 2000
PACIFIER THERMOMETER MODELS VT-901F, VT901C
K002562 · Valeo Corp. · Oct 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · Nien Made Electrnics Corp. · Aug 2000
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1
K000969 · Microlife Corp. · Aug 2000