Cleared Abbreviated

K082192 - INFRARED EAR THERMOMETER

K082192 is the FDA 510(k) clearance for INFRARED EAR THERMOMETER by Sejoy Electronics & Instruments Co., Ltd.. It is a Class 2 General Hospital device (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)
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.

View all Sejoy Electronics & Instruments Co., Ltd. devices

Submission Details

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
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.

Device Classification

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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K082192.
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
K090395 · Taidoc Technology Corporation · Mar 2009
FORA IR22 EAR THERMOMETER, MODEL TD-1262
K090294 · Taidoc Technology Corporation · Feb 2009
TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER
K083299 · Taidoc Technology Corporation · Dec 2008
FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A
K081445 · Taidoc Technology Corporation · Aug 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · Microlife Intellectual Property GmbH · Sep 2007