Cleared Traditional

K881568 - WILKENS CHALGREN BROTH

K881568 is the FDA 510(k) clearance for WILKENS CHALGREN BROTH by Acumedia Manufacturers, Inc.. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881568 · Acumedia Manufacturers, Inc. · Microbiology device
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Apr 1988
Decision
7d
Days
Class 2
Risk

K881568 is an FDA 510(k) clearance for the WILKENS CHALGREN BROTH. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Acumedia Manufacturers, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K881568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1988
Decision Date April 18, 1988
Days to Decision 7 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
95d faster than avg
Panel avg: 102d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 31
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K881568.
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · Remel Co. · Jun 1989
WILKENS CHALGREN AGAR
K881567 · Acumedia Manufacturers, Inc. · Apr 1988
WILKINS-CHALGREN ANAEROBE AGAR
K811513 · Oxoid U.S.A., Inc. · Jun 1981
GAR, COLUMBIA, W/5% HORSE BLOOD
K770441 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1977