Cleared Traditional

AEROBIC FOAM SWAB CULTURETTE(R) (K913789) - FDA 510(k) Clearance

Class I Microbiology device.

K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1991
Decision
47d
Days
Class 1
Risk

K913789 is an FDA 510(k) clearance for the AEROBIC FOAM SWAB CULTURETTE(R). Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 K913789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date October 09, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 29
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