Cleared Traditional

K942483 - CLINICAL GLASS THERMOMETER

K942483 is an FDA 510(k) clearance for CLINICAL GLASS THERMOMETER, manufactured by Makol Medical Instruments Corp.. The device is a Class 2 General Hospital device with product code FLK cleared through the Traditional 510(k) pathway after a 307-day FDA review.

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

FDA 510(k) Submission Details - K942483

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.

FLK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FLK Thermometer, Clinical Mercury

All 13
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K942483.
AMSINO CLINICAL THERMOMETER
K960185 · Amsia Intl., Inc. · Mar 1996
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
K960224 · Rg Ent., Inc. · Mar 1996
MEDIAID UNIVERSAL THERMOMETER
K941673 · Polymedica Industries, Inc. · Aug 1994
CLINICAL MERCURY THERMOMETER
K897054 · Cypress Medical Products, Ltd. · Mar 1990
GLASS MERCURY FILLED THERMOMETERS
K893602 · Smith & Nephew United, Inc. · Aug 1989
DISPOSABLE THERMOMETERS
K822502 · Hudson Oxygen Therapy Sales Co. · Sep 1982