Cleared Traditional

K894893 - POINT CHECKER COLOR STRIP THERMOMETER

K894893 is an FDA 510(k) clearance for POINT CHECKER COLOR STRIP THERMOMETER, manufactured by Kyowa Medex Co., Ltd.. The device is a Class 1 General Hospital device with product code FQZ cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K894893 · Kyowa Medex Co., Ltd. · General Hospital
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Apr 1990
Decision
247d
Days
Class 1
Risk

K894893 is an FDA 510(k) clearance for the POINT CHECKER COLOR STRIP THERMOMETER. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Kyowa Medex Co., Ltd. (Arlington, US). The FDA issued a Cleared decision on April 5, 1990 after a review of 247 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2900 - 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 Kyowa Medex Co., Ltd. devices

FDA 510(k) Submission Details - K894893

510(k) Number K894893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date April 05, 1990
Days to Decision 247 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 129d · This submission: 247d
Pathway characteristics
Predicate-based equivalence.

FQZ Device Classification - Class 1, General Controls

Product Code FQZ Thermometer, Clinical Color Change
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQZ Thermometer, Clinical Color Change

Devices cleared under the same product code (FQZ) and FDA review panel - the closest regulatory comparables to K894893.
CRY-ACTRACKERCAM
K110305 · Brymill Cryogenic Cystems · Jan 2012
STERI-AID KIT
K963049 · Steri-Aid, Inc. · Nov 1996
TEMPA-DOT CLINICAL THERMOMETER SHEATH
K881286 · Pymah Corp. · Jun 1988
TEMPO2-I DISPOSABLE THERMOMETERS
K790890 · Airlife, Inc. · Jun 1979
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K771038 · Organon, Inc. · Jun 1977