Cleared Traditional

MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (K873263) - FDA 510(k) Clearance

Class I Microbiology device.

K873263 · Central Media · Microbiology device
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Oct 1987
Decision
78d
Days
Class 1
Risk

K873263 is an FDA 510(k) clearance for the MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Central Media (Sacramento, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Central Media devices

Submission Details

510(k) Number K873263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date October 28, 1987
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 145
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K873263.
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
ARYLSULFATASE BROTH
K871701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
CLED AGAR
K871095 · bioMerieux, Inc. · Apr 1987
TRYCOPHYTON AGARS
K864100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
XANTHINE/TYROSINE/CASEIN AGAR
K863572 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
BIRD SEED AGAR
K863573 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986