Cleared Traditional

SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (K792349) - FDA 510(k) Clearance

Class I Microbiology device.

K792349 · Pfizer, Inc. · Microbiology device
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Mar 1980
Decision
114d
Days
Class 1
Risk

K792349 is an FDA 510(k) clearance for the SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.. Classified as Chromatographic, Phospholipids (product code JNT), Class I - General Controls.

Submitted by Pfizer, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1575 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pfizer, Inc. devices

Submission Details

510(k) Number K792349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date March 12, 1980
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 102d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JNT Chromatographic, Phospholipids
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1575
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.