Cleared Traditional

LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (K884208) - FDA 510(k) Clearance

Class I Microbiology device.

K884208 · Oxoid U.S.A., Inc. · Microbiology device
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Oct 1988
Decision
19d
Days
Class 1
Risk

K884208 is an FDA 510(k) clearance for the LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION). Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2330 - 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 K884208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date October 25, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 50
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K884208.
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
K872193 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
HORSE BLOOD AGAR, ENRICHED
K871092 · bioMerieux, Inc. · Apr 1987
VACUTAINER BRAND AGAR SLANT
K862761 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1986
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
K854064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
CHOCOLATE AGAR, ENRICHED
K830074 · bioMerieux, Inc. · Feb 1983
BLOOD AGAR(TSA W/5% SHEEP BLOOD)
K830078 · bioMerieux, Inc. · Feb 1983