Cleared Traditional

K772112 - NON-FERMENTER SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K772112 · Corning Medical & Scientific · Microbiology device
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Nov 1977
Decision
10d
Days
Class 1
Risk

K772112 is an FDA 510(k) clearance for the NON-FERMENTER SYSTEM. Classified as Kit, Identification, Glucose Nonfermenter (product code JSW), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on November 17, 1977 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K772112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1977
Decision Date November 17, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSW Kit, Identification, Glucose Nonfermenter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.