Cleared Traditional

K152748 - Braun Thermoscan PRO 6000 Ear Thermometer

K152748 is an FDA 510(k) clearance for Braun Thermoscan PRO 6000 Ear Thermometer, manufactured by Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K152748 · Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
160d
Days
Class 2
Risk

K152748 is an FDA 510(k) clearance for the Braun Thermoscan PRO 6000 Ear Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) (Southborough, US). The FDA issued a Cleared decision on March 1, 2016 after a review of 160 days - an extended review 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: 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 Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) devices

FDA 510(k) Submission Details - K152748

510(k) Number K152748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2015
Decision Date March 01, 2016
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
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 380
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K152748.
Non-contact Forehead Thermometer
K161735 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2016
Temperature Probe, Affinity Temperature Probe
K160091 · Medtronic, Inc. · May 2016
TD-1035 Thermometer
K152680 · Taidoc Technology Corporation · May 2016
Electronic Thermometer
K152739 · Guangdong Biolight Meditech Co., Ltd. · Feb 2016
BASAL DIGITAL THERMOMETER
K141505 · K-Jump Health Co., Ltd. · Aug 2014
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013