Cleared Traditional

BBL CAMPY POUCH (K853534) - FDA 510(k) Clearance

Class I Microbiology device.

K853534 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device

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Aug 1985

Decision

Days

Class 1

Risk

K853534 is an FDA 510(k) clearance for the BBL CAMPY POUCH. Classified as Device, Gas Generating (product code KZJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 6 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	K853534 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 23, 1985
Decision Date	August 29, 1985
Days to Decision	6 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

96d faster than avg

Panel avg: 102d · This submission: 6d

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 K853534.

BBL(R) GASPAK CO2 POUCH(TM)

K872782 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987

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

BBL ANAGEL POWDER

K832229 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1983

CAMPYPAK

K811957 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981

LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE

K800899 · Miles Laboratories, Inc. · May 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K853534

Bd Becton Dickinson Vacutainer Systems Preanalytic

Paramus, NJ · US

RUSSELL ARNSBERGER

Regulatory profile

632 submissions 625 cleared

99% clearance rate · Active in Microbiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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