Cleared Traditional

FRANKLIN COLLECTOR(R) (K884612) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

Device Classification

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.