Cleared Special

K102554 - AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES

K102554 is an FDA 510(k) clearance for AVITA SCANEO IR THERMOMETER MODEL TS4X ..., manufactured by Avita Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 177-day FDA review.

K102554 · Avita Corporation · General Hospital
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Mar 2011
Decision
177d
Days
Class 2
Risk

K102554 is an FDA 510(k) clearance for the AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on March 3, 2011 after a review of 177 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avita Corporation devices

FDA 510(k) Submission Details - K102554

510(k) Number K102554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date March 03, 2011
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K102554.
COTRONIC DIGITAL THERMOMETER
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IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488 · Shenzhen Dongdixin Technology Co., Ltd. · Jul 2010