Cleared Traditional

K134043 - NO TOUCH+FOREHEAD NTF 3000 THERMOMETER

K134043 is an FDA 510(k) clearance for NO TOUCH+FOREHEAD NTF 3000 THERMOMETER, manufactured by Kaz USA, Inc (A Subsidiaryof Kaz Inc). The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K134043 · Kaz USA, Inc (A Subsidiaryof Kaz Inc) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
141d
Days
Class 2
Risk

K134043 is an FDA 510(k) clearance for the NO TOUCH+FOREHEAD NTF 3000 THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Kaz USA, Inc (A Subsidiaryof Kaz Inc) (Southborough, US). The FDA issued a Cleared decision on May 21, 2014 after a review of 141 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.

View all Kaz USA, Inc (A Subsidiaryof Kaz Inc) devices

FDA 510(k) Submission Details - K134043

510(k) Number K134043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date May 21, 2014
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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 382
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K134043.
TD-1035 Thermometer
K152680 · Taidoc Technology Corporation · May 2016
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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
DIGITAL THERMOMTER
K122520 · Taidoc Technology Corporation · Feb 2013
NON-CONTACT THERMOMETER
K120711 · K-Jump Health Co., Ltd. · Nov 2012