Cleared Special

K091589 - MICROLIFE DIGITAL ELECTRONIC THERMOMETER

K091589 is an FDA 510(k) clearance for MICROLIFE DIGITAL ELECTRONIC THERMOMETER, 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 8-day FDA review.

K091589 · Microlife Intellectual Property GmbH · General Hospital
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Jun 2009
Decision
8d
Days
Class 2
Risk

K091589 is an FDA 510(k) clearance for the MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1. 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 June 10, 2009 after a review of 8 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 - K091589

510(k) Number K091589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date June 10, 2009
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
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 K091589.
AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
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FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · Taidoc Technology Corporation · Feb 2009