Cleared Traditional

MICROLIFE DIGITAL UNDERARM THERMOMETER (K103680) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103680 · Microlife Intellectual Property GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
110d
Days
Class 2
Risk

K103680 is an FDA 510(k) clearance for the MICROLIFE DIGITAL UNDERARM THERMOMETER. 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 April 6, 2011 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Microlife Intellectual Property GmbH devices

Submission Details

510(k) Number K103680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2010
Decision Date April 06, 2011
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 215
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K103680.
FORA COMFORTSCAN EAR THERMOMETER
K120712 · Taidoc Technology Corporation · Jun 2012
U-RIGHT TD-1240 THERMOMETER
K113159 · Taidoc Technology Corporation · Jan 2012
ION HEALTH USB INSTA-SCAN THERMOMETER
K111974 · Taidoc Technology Corporation · Aug 2011
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942 · Taidoc Technology Corporation · May 2010
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395 · Taidoc Technology Corporation · Mar 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · Taidoc Technology Corporation · Feb 2009