Cleared Traditional

ANA-DISC SYSTEM (K820308) - FDA 510(k) Clearance

Class I Microbiology device.

K820308 · Flow Laboratories, Inc. · Microbiology device

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Mar 1982

Decision

28d

Days

Class 1

Risk

K820308 is an FDA 510(k) clearance for the ANA-DISC SYSTEM. Classified as Device, Gas Generating (product code KZJ), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 28 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number	K820308 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 04, 1982
Decision Date	March 04, 1982
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

74d faster than avg

Panel avg: 102d · This submission: 28d

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 17

Devices cleared under the same product code (KZJ) and FDA review panel - the closest regulatory comparables to K820308.

BBL(R) GASPAK CO2 POUCH(TM)

K872782 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1987

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

BBL ANAGEL POWDER

K832229 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1983

CAMPYPAK

K811957 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981

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 K820308

Flow Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

57 submissions 56 cleared

98% 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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