Cleared Traditional

BAKTERIETTE-VI-PAK (K840719) - FDA 510(k) Clearance

Class I Microbiology device.

K840719 · Great Lakes Intl. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
47d
Days
Class 1
Risk

K840719 is an FDA 510(k) clearance for the BAKTERIETTE-VI-PAK. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Great Lakes Intl. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Great Lakes Intl. devices

Submission Details

510(k) Number K840719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1984
Decision Date April 04, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
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 JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K840719.
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
URINE CULTURE KIT
K790366 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1979
EPTONE BACK-UP BROTH, VACUTAINER
K771058 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1977
BOTTLE, BLOOD CULTURE, SCHAEDLER
K760458 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1976
CULTURE TUBE, (VACUTAINER)
K760054 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976