Cleared Traditional

K792349 - SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.

K792349 is an FDA 510(k) clearance for SUSCEPTIBILITY DISK, manufactured by Pfizer, Inc.. The device is a Class 1 Microbiology device with product code JNT cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

FDA 510(k) Submission Details - K792349

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 102d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

JNT Device Classification - Class 1, General Controls

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.