Cleared Traditional

BBL ANAGEL POWDER (K832229) - FDA 510(k) Clearance

Class I Microbiology device.

K832229 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Aug 1983
Decision
32d
Days
Class 1
Risk

K832229 is an FDA 510(k) clearance for the BBL ANAGEL POWDER. Classified as Device, Gas Generating (product code KZJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 32 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 K832229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date August 12, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 102d · This submission: 32d
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.

Regulatory Peers - KZJ Device, Gas Generating

All 8
Devices cleared under the same product code (KZJ) and FDA review panel - the closest regulatory comparables to K832229.
BBL CAMPY POUCH
K853534 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE
K844571 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
GASPAK PLUS DISPOS. HYDROGEN &
K841117 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
CAMPYPAK
K811957 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE
K800899 · Miles Laboratories, Inc. · May 1980
GAS PAK II DIS. GENERATOR ENVELOPES
K800796 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980