Cleared Traditional

K023956 - THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F

K023956 is an FDA 510(k) clearance for THERMOMETER MODELS ST313C/F, manufactured by Mesure Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 568-day FDA review.

K023956 · Mesure Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
568d
Days
Class 2
Risk

K023956 is an FDA 510(k) clearance for the THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Mesure Technology Co., Ltd. (San Chung City, TW). The FDA issued a Cleared decision on June 17, 2004 after a review of 568 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K023956

510(k) Number K023956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2002
Decision Date June 17, 2004
Days to Decision 568 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
439d slower than avg
Panel avg: 129d · This submission: 568d
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 695
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K023956.
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
K041516 · Vega Technologies, 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
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K033790 · Tecnimed S.R.L. · Jun 2004
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
K041056 · Mesure Technology Co., Ltd. · May 2004
EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
K033077 · Metatech Co., Ltd. · Apr 2004
K023956 · THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
Download PDF FDA Summary Mesure Technology Co.…