Cleared Traditional

K031503 - AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER

K031503 is an FDA 510(k) clearance for AVITA TS8/TS9 SERIES IR EAR/FOREHEAD TH..., 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 164-day FDA review.

K031503 · Avita Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
164d
Days
Class 2
Risk

K031503 is an FDA 510(k) clearance for the AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER. 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 October 24, 2003 after a review of 164 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 - K031503

510(k) Number K031503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2003
Decision Date October 24, 2003
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 797
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K031503.
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290
K033818 · Microlife Intellectual Property GmbH · Jan 2004
UP-GRADE FOREHEAD THERMOMETER
K032362 · Medisim, Ltd. · Dec 2003
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
K033082 · Metatech Co., Ltd. · Dec 2003
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT)
K031928 · Braun GmbH · Oct 2003
DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205
K033069 · Tenghi Co., Ltd. · Oct 2003
CARDICARE MODEL MT-301F & MT-301C
K032714 · Lumiscope Co., Inc. · Oct 2003
K031503 · AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
Download PDF FDA Summary Avita Corporation