Cleared Traditional

K872193 - FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W...

K872193 is the FDA 510(k) clearance for FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W... by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code KZI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K872193 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jun 1987
Decision
14d
Days
Class 1
Risk

K872193 is an FDA 510(k) clearance for the FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 22, 1987 after a review of 14 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K872193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date June 22, 1987
Days to Decision 14 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
88d faster than avg
Panel avg: 102d · This submission: 14d
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 34
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K872193.
IAFP LOWENSTEIN JENSEN SLANT
K872685 · I.A.F. Production, Inc. · Aug 1987
IAFP T.S.A. W/5% SHEEP BLOOD
K872671 · I.A.F. Production, Inc. · Aug 1987
IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1
K872678 · I.A.F. Production, Inc. · Aug 1987
TETRATHIONATE BROTH
K870634 · Hardy Media · Apr 1987
COOKED MEAT MEDIUM WITH IRON
K870642 · Hardy Media · Apr 1987
MIDDLEBROOK 7H10 AGAR
K870646 · Hardy Media · Apr 1987