Cleared Traditional

K092557 - DIGITAL THERMOMETER

K092557 is the FDA 510(k) clearance for DIGITAL THERMOMETER by Harvard Medical Devices , Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K092557 · Harvard Medical Devices , Ltd. · General Hospital
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Dec 2009
Decision
119d
Days
Class 2
Risk

K092557 is an FDA 510(k) clearance for the DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Harvard Medical Devices , Ltd. (Tsimshatsui, Kowloon, HK). The FDA issued a Cleared decision on December 17, 2009 after a review of 119 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 Harvard Medical Devices , Ltd. devices

Submission Details

510(k) Number K092557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date December 17, 2009
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 318
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K092557.
MICROLIFE DIGITAL UNDERARM THERMOMETER
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K100953 · Microlife Intellectual Property GmbH · May 2010
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
K091676 · Omron Healthcare, Inc. · Sep 2009
MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1
K091589 · Microlife Intellectual Property GmbH · Jun 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040 · Microlife Intellectual Property GmbH · May 2009