Cleared Traditional

K080759 - THERMOFLASH LX-26

K080759 is an FDA 510(k) clearance for THERMOFLASH LX-26, manufactured by Jxb Co. Ltd Guangzhou (China). The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K080759 · Jxb Co. Ltd Guangzhou (China) · General Hospital
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May 2008
Decision
55d
Days
Class 2
Risk

K080759 is an FDA 510(k) clearance for the THERMOFLASH LX-26. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Jxb Co. Ltd Guangzhou (China) (Panuy, Guangzhou, CN). The FDA issued a Cleared decision on May 12, 2008 after a review of 55 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jxb Co. Ltd Guangzhou (China) devices

FDA 510(k) Submission Details - K080759

510(k) Number K080759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date May 12, 2008
Days to Decision 55 days
Submission Type Traditional
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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 Peers - FLL Continuous Measurement Thermometer

All 420
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K080759.
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
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
K081160 · Avita Corporation · Jun 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
K073366 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2008
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · Microlife Intellectual Property GmbH · Sep 2007