Cleared Traditional

K841218 - CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR

K841218 is the FDA 510(k) clearance for CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR by Anaerobe Systems. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K841218 · Anaerobe Systems · Microbiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 1984

Decision

14d

Days

Class 1

Risk

K841218 is an FDA 510(k) clearance for the CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Anaerobe Systems devices

Submission Details

510(k) Number	K841218 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 22, 1984
Decision Date	April 05, 1984
Days to Decision	14 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

88d faster than avg

Panel avg: 102d · This submission: 14d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	JSI Culture Media, Selective And Differential
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 866.2360

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 - JSI Culture Media, Selective And Differential

All 187

Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K841218.

HAEMOPHILUS I.D. II TRIPLATE

K840338 · Remel Co. · Apr 1984

HAEMOPHILUS ID QUAD-PLATE

K841304 · Gibco Laboratories Life Technologies, Inc. · Apr 1984

LEVINE EOSIN METHYLENE BLUE AGAR

K841142 · Anaerobe Systems · Apr 1984

BACTEROIDES BILE ESCULIN GAR

K841222 · Anaerobe Systems · Apr 1984

MANNITOL SALT AGAR

K841134 · Anaerobe Systems · Mar 1984

MACCONKEY AGAR

K841141 · Anaerobe Systems · Mar 1984

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 K841218

Anaerobe Systems

Mchenry, IL · US

Regulatory profile

52 submissions 52 cleared

100% clearance rate · Active in Microbiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active