Cleared Traditional

K021048 - THERMOMETER MODELS ST8631

K021048 is an FDA 510(k) clearance for THERMOMETER MODELS ST8631, manufactured by Z7 International. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K021048 · Z7 International · General Hospital
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Apr 2002
Decision
21d
Days
Class 2
Risk

K021048 is an FDA 510(k) clearance for the THERMOMETER MODELS ST8631. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Z7 International (Acton, US). The FDA issued a Cleared decision on April 22, 2002 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. 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 - K021048

510(k) Number K021048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date April 22, 2002
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
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
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 791
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K021048.
DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
K021612 · Actherm, Inc. · May 2002
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
K021614 · Actherm, Inc. · May 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · Hivox Biotek, Inc. · May 2002
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · Global Treasure Industries , Ltd. · Apr 2002
MODEL GT980201 ELECTRONIC THERMOMETER
K021028 · Global Treasure , Ltd. · Apr 2002
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F
K013779 · Mesure Technology · Mar 2002
K021048 · THERMOMETER MODELS ST8631
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