Cleared Traditional

K180767 - FEMON Banana Thermometer

K180767 is the FDA 510(k) clearance for FEMON Banana Thermometer by Life Science Technology, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K180767 · Life Science Technology, Inc. · General Hospital
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Jan 2019
Decision
305d
Days
Class 2
Risk

K180767 is an FDA 510(k) clearance for the FEMON Banana Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Life Science Technology, Inc. (Seoul, KR). The FDA issued a Cleared decision on January 22, 2019 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Life Science Technology, Inc. devices

Submission Details

510(k) Number K180767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date January 22, 2019
Days to Decision 305 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
176d slower than avg
Panel avg: 129d · This submission: 305d
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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K180767.
Infrared thermometer
K182597 · Shenzhen Pango Electronic Co., Ltd. · Apr 2019
Tyto Thermometer
K190242 · Tyto Care , Ltd. · Mar 2019
Digital Thermometer
K182629 · Joytech Healthcare Co. , Ltd. · Feb 2019
Advocate Non-Contact Infrared Thermometer
K180355 · Broadmaster Biotech, Corp. · Jan 2019
Infrared Ear Thermometer
K180387 · Hetaida Technology Co., Ltd. · Jan 2019
Infrared Thermometer
K181215 · Shenzhen Finicare Co., Ltd. · Jan 2019