Cleared Traditional

K881569 - STUARTS TRANSPORT MEDIUM

K881569 is an FDA 510(k) clearance for STUARTS TRANSPORT MEDIUM, manufactured by Acumedia Manufacturers, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881569 · Acumedia Manufacturers, Inc. · Microbiology device
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Apr 1988
Decision
7d
Days
Class 1
Risk

K881569 is an FDA 510(k) clearance for the STUARTS TRANSPORT MEDIUM. Classified as Culture Media, Non-propagating Transport (product code JSM), 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 866.2390 - 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

FDA 510(k) Submission Details - K881569

510(k) Number K881569 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.

JSM Device Classification - Class 1, General Controls

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K881569.
CARY-BLAIR TRANSPORT SYSTEM
K885245 · Precision Biologicals, Inc. · Mar 1989
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · Acumedia Manufacturers, Inc. · Apr 1988
AMIES TRANSPORT MEDIUM
K881539 · Acumedia Manufacturers, Inc. · Apr 1988
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K872507 · Precision Dynamics Corp. · Jul 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K864998 · Boots-Celltech Diagnostics, Inc. · Apr 1987
CARY BLAIR TRANSPORT MEDIUM
K864237 · Mds Laboratories, Inc. · Mar 1987