Cleared Special

K051100 - MODIFICATION TO: MICROLIFE DIGITAL PACI...

K051100 is an FDA 510(k) clearance for MODIFICATION TO: MICROLIFE DIGITAL PACI..., 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 12-day FDA review.

K051100 · Microlife Intellectual Property GmbH · General Hospital
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May 2005
Decision
12d
Days
Class 2
Risk

K051100 is an FDA 510(k) clearance for the MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q. 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 May 11, 2005 after a review of 12 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 - K051100

510(k) Number K051100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date May 11, 2005
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
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 K051100.
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · Omron Healthcare, Inc. · Jun 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · Ge Healthcare · Apr 2005
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110 · Microlife Intellectual Property GmbH · Dec 2004
MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1
K033820 · Microlife Intellectual Property GmbH · Feb 2004