Cleared Traditional

INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 (K063291) - FDA 510(k) Clearance

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

K063291 · Choice Smart Health Care Co. , Ltd. · General Hospital
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Nov 2006
Decision
20d
Days
Class 2
Risk

K063291 is an FDA 510(k) clearance for the INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Choice Smart Health Care Co. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 21, 2006 after a review of 20 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 Choice Smart Health Care Co. , Ltd. devices

Submission Details

510(k) Number K063291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date November 21, 2006
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 228
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K063291.
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445 · Taidoc Technology Corporation · Aug 2008
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K080593 · Taidoc Technology Corporation · Apr 2008
ACON DIGITAL THERMOMETER PROBE COVERS
K063418 · ACON Laboratories, Inc. · Feb 2007
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942 · Ge Healthcare · Sep 2006
CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
K061800 · Taidoc Technology Corporation · Jul 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173 · ACON Laboratories, Inc. · Mar 2006