Cleared Traditional

K881563 - TRYPTOSE PHOSPHATE BROTH

K881563 is the FDA 510(k) clearance for TRYPTOSE PHOSPHATE BROTH by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881563 · Acumedia Manufacturers, Inc. · Microbiology device
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Apr 1988
Decision
7d
Days
Class 1
Risk

K881563 is an FDA 510(k) clearance for the TRYPTOSE PHOSPHATE BROTH. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General 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 866.2300 - 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 K881563 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.

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 K881563.
TRYPTONE
K881557 · Acumedia Manufacturers, Inc. · Apr 1988
TRYPTOSE AGAR
K881558 · Acumedia Manufacturers, Inc. · Apr 1988
TRYPTOSE BLOOD AGAR BASE
K881562 · Acumedia Manufacturers, Inc. · Apr 1988
TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT
K881564 · Acumedia Manufacturers, Inc. · Apr 1988
NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE
K880947 · Lakewood Biochemical Co., Inc. · Apr 1988
TSA W/LEC. & TWEEN. 80
K880142 · Hardy Media · Mar 1988