Cleared Special

K062867 - MICROLIFE INSTANT DIGITAL ELECTRONIC TH...

K062867 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 72-day FDA review.

K062867 · Microlife Intellectual Property GmbH · General Hospital
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Dec 2006
Decision
72d
Days
Class 2
Risk

K062867 is an FDA 510(k) clearance for the MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1. 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 6, 2006 after a review of 72 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 - K062867

510(k) Number K062867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date December 06, 2006
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K062867.
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K061800 · Taidoc Technology Corporation · Jul 2006
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K060240 · K-Jump Health Co., Ltd. · May 2006