Cleared Abbreviated

K082192 - INFRARED EAR THERMOMETER, MODEL ET-101A

K082192 is an FDA 510(k) clearance for INFRARED EAR THERMOMETER, manufactured by Sejoy Electronics & Instruments Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Abbreviated 510(k) pathway after a 44-day FDA review.

K082192 · Sejoy Electronics & Instruments Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
44d
Days
Class 2
Risk

K082192 is an FDA 510(k) clearance for the INFRARED EAR THERMOMETER, MODEL ET-101A. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sejoy Electronics & Instruments Co., Ltd. (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on September 17, 2008 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K082192

510(k) Number K082192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date September 17, 2008
Days to Decision 44 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Center For Measurement Standards of Industrial
TZU-WEI LI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K082192.
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FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445 · Taidoc Technology Corporation · Aug 2008
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
K081061 · Harvard Medical Devices , Ltd. · Jul 2008
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
K081160 · Avita Corporation · Jun 2008

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K082192 · INFRARED EAR THERMOMETER, MODEL ET-101A
Download PDF FDA Summary Sejoy Electronics & I…