Cleared Traditional

CLINICAL GLASS THERMOMETER (K942483) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942483 · Makol Medical Instruments Corp. · General Hospital
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Mar 1995
Decision
307d
Days
Class 2
Risk

K942483 is an FDA 510(k) clearance for the CLINICAL GLASS THERMOMETER. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Makol Medical Instruments Corp. (Miami, US). The FDA issued a Cleared decision on March 28, 1995 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2920 - 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. Elevated predicate reliance profile. 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 Makol Medical Instruments Corp. devices

Submission Details

510(k) Number K942483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date March 28, 1995
Days to Decision 307 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
178d slower than avg
Panel avg: 129d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLK Thermometer, Clinical Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2920
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.