Cleared Traditional

K884612 - FRANKLIN COLLECTOR(R)

K884612 is an FDA 510(k) clearance for FRANKLIN COLLECTOR, manufactured by Franklin Diagnostics, Inc.. The device is a Class 1 General Hospital device with product code FQZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K884612 · Franklin Diagnostics, Inc. · General Hospital
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Mar 1989
Decision
143d
Days
Class 1
Risk

K884612 is an FDA 510(k) clearance for the FRANKLIN COLLECTOR(R). Classified as Thermometer, Clinical Color Change (product code FQZ), Class I - General Controls.

Submitted by Franklin Diagnostics, Inc. (Morristown, US). The FDA issued a Cleared decision on March 27, 1989 after a review of 143 days - within the typical 510(k) review window.

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 Franklin Diagnostics, Inc. devices

FDA 510(k) Submission Details - K884612

510(k) Number K884612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date March 27, 1989
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
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 K884612.
CRY-ACTRACKERCAM
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THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K771038 · Organon, Inc. · Jun 1977