Cleared Traditional

K051699 - SEJOY

K051699 is the FDA 510(k) clearance for SEJOY by Sejoy Electronics & Instruments Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K051699 · Sejoy Electronics & Instruments Co., Ltd. · General Hospital
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Feb 2006
Decision
227d
Days
Class 2
Risk

K051699 is an FDA 510(k) clearance for the SEJOY, MODEL MT-403. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sejoy Electronics & Instruments Co., Ltd. (San Jose, US). The FDA issued a Cleared decision on February 6, 2006 after a review of 227 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 Sejoy Electronics & Instruments Co., Ltd. devices

Submission Details

510(k) Number K051699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2005
Decision Date February 06, 2006
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K051699.
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942 · Ge Healthcare · Sep 2006
CLEVER TD-1112 EAR/SKIN/SURFACE IR THERMOMETER
K061800 · Taidoc Technology Corporation · Jul 2006
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
K060173 · ACON Laboratories, Inc. · Mar 2006
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · Omron Healthcare, Inc. · Jun 2005