Cleared Traditional

K864237 - CARY BLAIR TRANSPORT MEDIUM

K864237 is the FDA 510(k) clearance for CARY BLAIR TRANSPORT MEDIUM by Mds Laboratories, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864237 · Mds Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
154d
Days
Class 1
Risk

K864237 is an FDA 510(k) clearance for the CARY BLAIR TRANSPORT MEDIUM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mds Laboratories, Inc. devices

Submission Details

510(k) Number K864237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 53
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K864237.
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · Acumedia Manufacturers, Inc. · Apr 1988
AMIES TRANSPORT MEDIUM
K881539 · Acumedia Manufacturers, Inc. · Apr 1988
STUARTS TRANSPORT MEDIUM
K881569 · Acumedia Manufacturers, Inc. · Apr 1988
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · Kallestad Laboratories, Inc. · Oct 1986
BUFFERED GLYCEROL SALINE
K863602 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986