Cleared Traditional

K811353 - BRAIN HEART INFUSION W/O DEXTROSE

K811353 is the FDA 510(k) clearance for BRAIN HEART INFUSION W/O DEXTROSE by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811353 · Acumedia Manufacturers, Inc. · Microbiology device
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May 1981
Decision
15d
Days
Class 1
Risk

K811353 is an FDA 510(k) clearance for the BRAIN HEART INFUSION W/O DEXTROSE. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 29, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 K811353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1981
Decision Date May 29, 1981
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K811353.
TRYPTIC SOY AGAR
K811612 · Micro Media Laboratories · Jun 1981
THIOGLYCOLLATE MED. W/OUT INDICATOR
K811515 · Oxoid U.S.A., Inc. · Jun 1981
THIOGLYCOLLATE MEDIUM W/OUT INDICATOR
K811340 · Acumedia Manufacturers, Inc. · May 1981
AGAR, BACTERIOLOGICAL
K811359 · Acumedia Manufacturers, Inc. · May 1981
STANDARD METHODS AGAR
K811321 · Acumedia Manufacturers, Inc. · May 1981
FLUID THIOGLYCOLLATE MEDIUM
K811047 · Acumedia Manufacturers, Inc. · May 1981