Cleared Traditional

K002182 - AVITA TSO/TS1 INFRARED EAR THERMOMETER

K002182 is an FDA 510(k) clearance for AVITA TSO/TS1 INFRARED EAR THERMOMETER, manufactured by Avita Corporation. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K002182 · Avita Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
163d
Days
Class 2
Risk

K002182 is an FDA 510(k) clearance for the AVITA TSO/TS1 INFRARED EAR THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Avita Corporation (Flaggstaff, US). The FDA issued a Cleared decision on December 29, 2000 after a review of 163 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K002182

510(k) Number K002182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2000
Decision Date December 29, 2000
Days to Decision 163 days
Submission Type Traditional
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
34d slower than avg
Panel avg: 129d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K002182.
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
K010238 · Actherm, Inc. · Feb 2001
GEON DIGITAL CLINICAL THERMOMETER
K003223 · Geon Corp. · Jan 2001
FILAC FAS TEMP ELECTRONIC THERMOMETER
K003313 · The Kendall Company · Jan 2001
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
K003308 · Microlife Corp. · Nov 2000
PACIFIER THERMOMETER MODELS VT-901F, VT901C
K002562 · Valeo Corp. · Oct 2000
CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999
K993950 · Nien Made Electrnics Corp. · Aug 2000
K002182 · AVITA TSO/TS1 INFRARED EAR THERMOMETER
Download PDF FDA Summary Avita Corporation