Cleared Traditional

K021028 - MODEL GT980201 ELECTRONIC THERMOMETER

K021028 is an FDA 510(k) clearance for MODEL GT980201 ELECTRONIC THERMOMETER, manufactured by Global Treasure , Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K021028 · Global Treasure , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
10d
Days
Class 2
Risk

K021028 is an FDA 510(k) clearance for the MODEL GT980201 ELECTRONIC THERMOMETER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Global Treasure , Ltd. (18 Tin Hau Road, Tuen Mun N.T., HK). The FDA issued a Cleared decision on April 8, 2002 after a review of 10 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021028

510(k) Number K021028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date April 08, 2002
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
N.E. DEVINE JR.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 791
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K021028.
HIVOX EAR THERMOMETER, TS SERIES
K020471 · Hivox Biotek, Inc. · May 2002
THERMOMETER MODELS ST8631
K021048 · Z7 International · Apr 2002
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · Global Treasure Industries , Ltd. · Apr 2002
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
K013779 · Mesure Technology · Mar 2002
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
K020725 · Microlife Corp. · Mar 2002
INFRARED EAR THERMOMETER, MODEL DX-707
K013876 · Jawon Medical Co., Ltd. · Mar 2002

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K021028 · MODEL GT980201 ELECTRONIC THERMOMETER
Download PDF FDA Summary Global Treasure , Ltd.