Cleared Traditional

K041516 - DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9

K041516 is an FDA 510(k) clearance for DIGITAL THERMOMETER, manufactured by Vega Technologies, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K041516 · Vega Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
96d
Days
Class 2
Risk

K041516 is an FDA 510(k) clearance for the DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Vega Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on September 8, 2004 after a review of 96 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 - K041516

510(k) Number K041516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2004
Decision Date September 08, 2004
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
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 663
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K041516.
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · Hangzhou Hua'An Medical & Health Instruments Co., · Sep 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
K041694 · Hangzhou Hua'An Medical & Health Instruments Co., · Sep 2004
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502
K042202 · Oriental System Technology, Inc. · Sep 2004
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
K042013 · Mesure Technology Co., Ltd. · Sep 2004
THERMOTEK Q5
K041646 · Saat , Ltd. · Jul 2004
THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
K023956 · Mesure Technology Co., Ltd. · Jun 2004