Cleared Traditional

K102947 - NON-CONTACT INFRARED THERMOMETER

K102947 is an FDA 510(k) clearance for NON-CONTACT INFRARED THERMOMETER, manufactured by K-Jump Health Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K102947 · K-Jump Health Co., Ltd. · General Hospital
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Feb 2011
Decision
144d
Days
Class 2
Risk

K102947 is an FDA 510(k) clearance for the NON-CONTACT INFRARED THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on February 25, 2011 after a review of 144 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 K-Jump Health Co., Ltd. devices

FDA 510(k) Submission Details - K102947

510(k) Number K102947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date February 25, 2011
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 129d · This submission: 144d
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 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K102947.
MICROLIFE DIGITAL UNDERARM THERMOMETER
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K102554 · Avita Corporation · Mar 2011
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
K103800 · Kaz USA, Inc (A Subsidiaryof Kaz Inc) · Jan 2011
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
K100488 · Shenzhen Dongdixin Technology Co., Ltd. · Jul 2010
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942 · Taidoc Technology Corporation · May 2010