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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 697
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K080759.
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
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AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
K081160 · Avita Corporation · Jun 2008
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
K081256 · Rio Flexon Technology Co., Ltd. · May 2008
TEMPTOUCH DERMAL THERMOMETER
K081162 · Diabetica Solutions, Inc. · May 2008
EAR THERMOMETER, MODELS ST66 AND ST67
K080981 · Mesure Technology Co., Ltd. · May 2008
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
K080593 · Taidoc Technology Corporation · Apr 2008

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K080759 · THERMOFLASH LX-26
Download PDF FDA Summary Jxb Co. Ltd Guangzhou…