Cleared Traditional

K802494 - GAS GENERATING KIT SYSTEM FOR CAMPYLOB.

K802494 is the FDA 510(k) clearance for GAS GENERATING KIT SYSTEM FOR CAMPYLOB. by Oxoid U.S.A., Inc.. It is a Class 1 Microbiology device (product code KZJ) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K802494 · Oxoid U.S.A., Inc. · Microbiology device
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Nov 1980
Decision
33d
Days
Class 1
Risk

K802494 is an FDA 510(k) clearance for the GAS GENERATING KIT SYSTEM FOR CAMPYLOB.. Classified as Device, Gas Generating (product code KZJ), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2580 - 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 Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K802494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1980
Decision Date November 12, 1980
Days to Decision 33 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
69d faster than avg
Panel avg: 102d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZJ Device, Gas Generating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2580
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 - KZJ Device, Gas Generating

All 14
Devices cleared under the same product code (KZJ) and FDA review panel - the closest regulatory comparables to K802494.
ANA-DISC SYSTEM
K820308 · Flow Laboratories, Inc. · Mar 1982
GAS GENERATING KIT, CO2
K820010 · Oxoid U.S.A., Inc. · Jan 1982
CAMPYPAK
K811957 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE
K800899 · Miles Laboratories, Inc. · May 1980
GAS PAK II DIS. GENERATOR ENVELOPES
K800796 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
DISP. HYDROGEN & CO2 GENERATOR ENVELOPE
K800539 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980