Cleared Traditional

K853515 - PEE WEE THERMOMETERS

K853515 is an FDA 510(k) clearance for PEE WEE THERMOMETERS, manufactured by Joel R.L. Ehren Kranz. The device is a Class 1 General Hospital device with product code FQZ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K853515 · Joel R.L. Ehren Kranz · General Hospital
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Oct 1985
Decision
55d
Days
Class 1
Risk

K853515 is an FDA 510(k) clearance for the PEE WEE THERMOMETERS. Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Joel R.L. Ehren Kranz (Morristown, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Joel R.L. Ehren Kranz devices

FDA 510(k) Submission Details - K853515

510(k) Number K853515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1985
Decision Date October 16, 1985
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K853515.
CRY-ACTRACKERCAM
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STERI-AID KIT
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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