Cleared Special

K083299 - TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER

K083299 is an FDA 510(k) clearance for TAIDOC TD-11 SERIES AND CLEVER TD-1112 ..., manufactured by Taidoc Technology Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 30-day FDA review.

K083299 · Taidoc Technology Corporation · General Hospital
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Dec 2008
Decision
30d
Days
Class 2
Risk

K083299 is an FDA 510(k) clearance for the TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FO.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 10, 2008 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K083299

510(k) Number K083299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date December 10, 2008
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K083299.
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395 · Taidoc Technology Corporation · Mar 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · Taidoc Technology Corporation · Feb 2009
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
K081788 · Innochips Technology Co., Ltd. · Dec 2008
DIGITAL CLINICAL THERMOMETER MODEL V9XX
K082266 · Amperor-Electronic(Sz) Co., Ltd. · Nov 2008
INFRARED EAR THERMOMETER, MODEL ET-101A
K082192 · Sejoy Electronics & Instruments Co., Ltd. · Sep 2008
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445 · Taidoc Technology Corporation · Aug 2008
K083299 · TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
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