Cleared Special

K043110 - MICROLIFE INSTANT DIGITAL ELECTRONIC TH...

K043110 is an FDA 510(k) clearance for MICROLIFE INSTANT DIGITAL ELECTRONIC TH..., manufactured by Microlife Intellectual Property GmbH. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 29-day FDA review.

K043110 · Microlife Intellectual Property GmbH · General Hospital
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Dec 2004
Decision
29d
Days
Class 2
Risk

K043110 is an FDA 510(k) clearance for the MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Microlife Intellectual Property GmbH (Great Neck, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 29 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.

View all Microlife Intellectual Property GmbH devices

FDA 510(k) Submission Details - K043110

510(k) Number K043110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2004
Decision Date December 09, 2004
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 362
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K043110.
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · Omron Healthcare, Inc. · Jun 2005
MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q
K051100 · Microlife Intellectual Property GmbH · May 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · Ge Healthcare · Apr 2005
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820 · Microlife Intellectual Property GmbH · Feb 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023 · Microlife Intellectual Property GmbH · Jan 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
K033817 · Microlife Intellectual Property GmbH · Jan 2004