Cleared Traditional

HORSE BLOOD AGAR, ENRICHED (K871092) - FDA 510(k) Clearance

Class I Microbiology device.

K871092 · bioMerieux, Inc. · Microbiology device
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Apr 1987
Decision
16d
Days
Class 1
Risk

K871092 is an FDA 510(k) clearance for the HORSE BLOOD AGAR, ENRICHED. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 16 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K871092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 03, 1987
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
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 K871092.
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
K872193 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 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