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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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 797
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K102554.
COTRONIC DIGITAL THERMOMETER
K103407 · Cotronic Manufacturing · May 2011
MICROLIFE DIGITAL UNDERARM THERMOMETER
K103680 · Microlife Intellectual Property GmbH · Apr 2011
DIGITAL FOREHEAD THERMOMETER
K103617 · K-Jump Health Co., Ltd. · Apr 2011
NON-CONTACT INFRARED THERMOMETER
K102947 · K-Jump Health Co., Ltd. · Feb 2011
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
K103800 · Kaz USA, Inc (A Subsidiaryof Kaz Inc) · Jan 2011
INFRARED EAR THERMOMETER, MODEL IR-04MT
K102934 · Vega Technologies, Inc. · Jan 2011
K102554 · AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
Download PDF Avita Corporation