Cleared Traditional

K800539 - DISP. HYDROGEN & CO2 GENERATOR ENVELOPE (FDA 510(k) Clearance)

Class I Microbiology device.

K800539 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Apr 1980
Decision
29d
Days
Class 1
Risk

K800539 is an FDA 510(k) clearance for the DISP. HYDROGEN & CO2 GENERATOR ENVELOPE. Classified as Device, Gas Generating (product code KZJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2580 - 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 K800539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1980
Decision Date April 08, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZJ Device, Gas Generating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2580
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.