Cleared Traditional

K121118 - FORA COMFORTSCAN EAR THERMOMETER

K121118 is an FDA 510(k) clearance for FORA COMFORTSCAN EAR THERMOMETER, manufactured by Foracare, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K121118 · Foracare, Inc. · General Hospital
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Jun 2012
Decision
64d
Days
Class 2
Risk

K121118 is an FDA 510(k) clearance for the FORA COMFORTSCAN EAR THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Foracare, Inc. (Taipei County, TW). The FDA issued a Cleared decision on June 15, 2012 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Foracare, Inc. devices

FDA 510(k) Submission Details - K121118

510(k) Number K121118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date June 15, 2012
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 378
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K121118.
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013
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K122520 · Taidoc Technology Corporation · Feb 2013
NON-CONTACT THERMOMETER
K120711 · K-Jump Health Co., Ltd. · Nov 2012
FORA COMFORTSCAN EAR THERMOMETER
K120712 · Taidoc Technology Corporation · Jun 2012
UNIMED TEMPERATURE PROBE
K121427 · Unimed Medical Supplies, Inc. · May 2012
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
K113141 · Microlife Intellectual Property GmbH · Jan 2012