Cleared Special

K042627 - EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65

K042627 is an FDA 510(k) clearance for EAR THERMOMETER MODELS ST61, manufactured by Mesure Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 21-day FDA review.

K042627 · Mesure Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
21d
Days
Class 2
Risk

K042627 is an FDA 510(k) clearance for the EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65. 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 October 18, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042627

510(k) Number K042627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date October 18, 2004
Days to Decision 21 days
Submission Type Special
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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K042627.
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1
K043110 · Microlife Intellectual Property GmbH · Dec 2004
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
K042653 · Pack & Proper Co., Ltd. · Nov 2004
AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
K042906 · Amplife Corporation · Nov 2004
AMPLIFE DIGITAL CLINICAL THERMOMETER
K042575 · Amplife Corporation · Sep 2004
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
K040377 · Radiant Innovation, Inc. · Sep 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · Hangzhou Hua'An Medical & Health Instruments Co., · Sep 2004
K042627 · EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65
Download PDF FDA Summary Mesure Technology Co.…