Cleared Traditional

K172427 - AViTA Radar Thermo NT16 Series IR Therm...

K172427 is an FDA 510(k) clearance for AViTA Radar Thermo NT16 Series IR Therm..., 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 252-day FDA review.

K172427 · Avita Corporation · General Hospital
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Apr 2018
Decision
252d
Days
Class 2
Risk

K172427 is an FDA 510(k) clearance for the AViTA Radar Thermo NT16 Series IR Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on April 19, 2018 after a review of 252 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.

View all Avita Corporation devices

FDA 510(k) Submission Details - K172427

510(k) Number K172427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2017
Decision Date April 19, 2018
Days to Decision 252 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
123d slower than avg
Panel avg: 129d · This submission: 252d
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 377
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K172427.
Infrared Thermometer
K172889 · Shenzhen Pacom Medical Instruments Co., Ltd. · May 2018
Infrared Thermometer
K172894 · Shenzhen Jiacom Technology CO ., Ltd. · May 2018
Infrared Body Thermometer
K180385 · Hetaida Technology Co., Ltd. · May 2018
ATS Thermal Imaging Probe, ATS Patient Interface Unit
K180148 · Securus Medical Group, Inc. · Mar 2018
Infrared Thermometer
K172795 · Shenzhen Jumper Medical Equipment Co., Ltd. · Mar 2018
Infrared Thermometer
K171214 · Shenzhen Brav Electronic Technologies Co., Ltd. · Mar 2018