Cleared Traditional

K855172 - KWI (TM) G-CO/TWO

K855172 is the FDA 510(k) clearance for KWI (TM) G-CO/TWO by Micro-Bio-Logics. It is a Class 1 Microbiology device (product code JSK) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K855172 · Micro-Bio-Logics · Microbiology device
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Feb 1986
Decision
56d
Days
Class 1
Risk

K855172 is an FDA 510(k) clearance for the KWI (TM) G-CO/TWO. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on February 20, 1986 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - 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.

View all Micro-Bio-Logics devices

Submission Details

510(k) Number K855172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 20, 1986
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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 - JSK Supplement, Culture Media

All 57
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K855172.
PENICILLIN-STREPTOMYCIN-FUNGIZONE
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GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
K861824 · Flow Laboratories, Inc. · May 1986
ABBOTT CATION SUPPLEMENT SOLUTION
K853546 · Abbott Laboratories · Sep 1985
PRESTON CAMPYLOBACTER SELECTIVE SUPP
K840330 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · Oxoid U.S.A., Inc. · May 1984