Cleared Traditional

K113095 - E-CARE INFRARED EAR THERMOMETER

K113095 is an FDA 510(k) clearance for E-CARE INFRARED EAR THERMOMETER, manufactured by E-Care Technology Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K113095 · E-Care Technology Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
135d
Days
Class 2
Risk

K113095 is an FDA 510(k) clearance for the E-CARE INFRARED EAR THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by E-Care Technology Corporation (Chubei, TW). The FDA issued a Cleared decision on March 2, 2012 after a review of 135 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.

FDA 510(k) Submission Details - K113095

510(k) Number K113095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date March 02, 2012
Days to Decision 135 days
Submission Type Traditional
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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 679
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K113095.
3M SPOTON TEMPERATURE MONITORING SYSTEM
K120412 · Arizant Healthcare, Inc. · May 2012
UNIMED TEMPERATURE PROBE
K121427 · Unimed Medical Supplies, Inc. · May 2012
INFRARED EAR THEROMETER
K111703 · Fudakang Industrial Co., Ltd. · Mar 2012
VALEO VT-601 SERIES IR THERMOMETER
K111463 · Valeo Corp. · Feb 2012
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
K113141 · Microlife Intellectual Property GmbH · Jan 2012
THERMO PAL INFRARED EAR THERMOMETER
K112189 · Digio2 International Co., Ltd. · Jan 2012
K113095 · E-CARE INFRARED EAR THERMOMETER
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