Cleared Abbreviated

K031928 - BRAUN THERMOSCAN PRO 4000 SERIES (PROFE...

Also marketed or referenced as:
BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)

K031928 is the FDA 510(k) clearance for BRAUN THERMOSCAN PRO 4000 SERIES (PROFE... by Braun GmbH. It is a Class 2 General Hospital device (product code FLL) cleared through the Abbreviated 510(k) pathway after a 123-day FDA review.

K031928 · Braun GmbH · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
123d
Days
Class 2
Risk

K031928 is an FDA 510(k) clearance for the BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT). Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Braun GmbH (Carlsbad, US). The FDA issued a Cleared decision on October 24, 2003 after a review of 123 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Braun GmbH devices

Submission Details

510(k) Number K031928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date October 24, 2003
Days to Decision 123 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 129d · This submission: 123d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 319
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