Cleared Traditional

K021753 - E-CARE INFARED EAR THERMOMETER, MODEL LCT-200

K021753 is an FDA 510(k) clearance for E-CARE INFARED 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 69-day FDA review.

K021753 · E-Care Technology Corporation · General Hospital
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Aug 2002
Decision
69d
Days
Class 2
Risk

K021753 is an FDA 510(k) clearance for the E-CARE INFARED EAR THERMOMETER, MODEL LCT-200. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by E-Care Technology Corporation (Great Neck, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 69 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 E-Care Technology Corporation devices

FDA 510(k) Submission Details - K021753

510(k) Number K021753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2002
Decision Date August 06, 2002
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 399
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K021753.
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658 · Microlife Intellectual Property GmbH · Sep 2003
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JA1
K031958 · Microlife Intellectual Property GmbH · Aug 2003
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K021851 · K-Jump Health Co., Ltd. · Jul 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · Hivox Biotek, Inc. · May 2002
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · Avita Corporation · Sep 2001