Cleared Traditional

E-VAC BLOOD CULTURE SYSTEM (K802408) - FDA 510(k) Clearance

Class I Microbiology device.

K802408 · Pfizer Pharmaceuticals · Microbiology device
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Oct 1980
Decision
20d
Days
Class 1
Risk

K802408 is an FDA 510(k) clearance for the E-VAC BLOOD CULTURE SYSTEM. Classified as Culture Media, General Nutrient Broth (product code JSC), Class I - General Controls.

Submitted by Pfizer Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2350 - 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 Pfizer Pharmaceuticals devices

Submission Details

510(k) Number K802408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1980
Decision Date October 23, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSC Culture Media, General Nutrient Broth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2350
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 - JSC Culture Media, General Nutrient Broth

All 51
Devices cleared under the same product code (JSC) and FDA review panel - the closest regulatory comparables to K802408.
SABOURAUD BHI AGAR
K833300 · Acumedia Manufacturers, Inc. · Nov 1983
INFUSION BROTH
K832569 · Acumedia Manufacturers, Inc. · Sep 1983
EXTRACT BROTH
K832570 · Acumedia Manufacturers, Inc. · Sep 1983
MINITEK GRAM-POSITIVE BROTH & SET AND
K822487 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982
NUTRIENT BROTH
K811323 · Acumedia Manufacturers, Inc. · May 1981
PEPTONE YEAST EXTRACT GLUCOSE BROTH
K803026 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980