Cleared Traditional

K162509 - Infrared Non-contact Thermometer, Model ACT8100

K162509 is an FDA 510(k) clearance for Infrared Non-contact Thermometer, manufactured by Easywell Biomedicals, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K162509 · Easywell Biomedicals, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
183d
Days
Class 2
Risk

K162509 is an FDA 510(k) clearance for the Infrared Non-contact Thermometer, Model ACT8100. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Easywell Biomedicals, Inc. (Hsinchu, TW). The FDA issued a Cleared decision on March 10, 2017 after a review of 183 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 - K162509

510(k) Number K162509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date March 10, 2017
Days to Decision 183 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 129d · This submission: 183d
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 663
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K162509.
Braun No Touch + Forehead NTF3000 Thermometer
K163516 · Kaz USA, Inc., A Helen of Troy Company · Apr 2017
VisioFocus Mini, VisioFocus Smart
K160680 · Tecnimed S.R.L. · Apr 2017
Dual Mode Infrared Thermometer
K163256 · Intelliworks, LLC · Apr 2017
DT-100
K160358 · Mediana Co., Ltd. · Feb 2017
Fever Scout™ Continuous Monitoring thermometer
K162137 · VivaLNK, Inc. · Jan 2017
RII Multi-function Infrared Thermometer, Model TH52Z
K162083 · Radiant Innovation, Inc. · Jan 2017