Cleared Traditional

K102508 - YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

K102508 is an FDA 510(k) clearance for YU LONG SHENG DISPOSABLE THERMOMETER SH..., manufactured by Yu Long Sheng Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K102508 · Yu Long Sheng Technology Co., Ltd. · General Hospital
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Jan 2011
Decision
131d
Days
Class 2
Risk

K102508 is an FDA 510(k) clearance for the YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Yu Long Sheng Technology Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on January 10, 2011 after a review of 131 days - within the typical 510(k) review window.

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 Yu Long Sheng Technology Co., Ltd. devices

FDA 510(k) Submission Details - K102508

510(k) Number K102508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2010
Decision Date January 10, 2011
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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 405
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