Cleared Special

K111974 - ION HEALTH USB INSTA-SCAN THERMOMETER

K111974 is an FDA 510(k) clearance for ION HEALTH USB INSTA-SCAN THERMOMETER, 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 34-day FDA review.

K111974 · Taidoc Technology Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
34d
Days
Class 2
Risk

K111974 is an FDA 510(k) clearance for the ION HEALTH USB INSTA-SCAN THERMOMETER. 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 August 15, 2011 after a review of 34 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 - K111974

510(k) Number K111974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2011
Decision Date August 15, 2011
Days to Decision 34 days
Submission Type Special
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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 733
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K111974.
SHAKER DIGITAL THERMOMETER
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DIGITAL THERMOMETER MT SERIES
K110776 · Sejoy Electronics & Instruments Co., Ltd. · Aug 2011
DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
K111282 · Starboard Medical, LLC · Aug 2011
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K110956 · Medivance, Inc. · Jul 2011
BEHIND EAR GENTLE TOUCH THERMOMETER
K103839 · Kaz, Inc. · Jun 2011
K111974 · ION HEALTH USB INSTA-SCAN THERMOMETER
Download PDF FDA Summary Taidoc Technology Cor…