Cleared Traditional

DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 (K041516) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041516 · Vega Technologies, Inc. · General Hospital
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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.

View all Vega Technologies, Inc. devices

Submission Details

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
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.

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 216
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K041516.
DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
K051873 · Ge Healthcare · Sep 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER
K050463 · Taidoc Technology Corporation · Jul 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · Ge Healthcare · Apr 2005
SURETEMP PLUS
K030580 · Welch Allyn, Inc. · May 2003
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
DIGITAL THERMOMETER KITS
K905025 · Abco Dealers, Inc. · Feb 1991