Cleared Traditional

K100843 - ABREU, MODEL 700

K100843 is an FDA 510(k) clearance for ABREU, manufactured by Brain Tunnelgenix Technologies Corp. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K100843 · Brain Tunnelgenix Technologies Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
145d
Days
Class 2
Risk

K100843 is an FDA 510(k) clearance for the ABREU, MODEL 700. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Brain Tunnelgenix Technologies Corp (Naples, US). The FDA issued a Cleared decision on August 17, 2010 after a review of 145 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.

FDA 510(k) Submission Details - K100843

510(k) Number K100843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2010
Decision Date August 17, 2010
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 681
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K100843 · ABREU, MODEL 700
Download PDF FDA Summary Brain Tunnelgenix Tec…