Cleared Traditional

K024240 - BD VACUTAINER PLUS PLASTIC URINE C&S PR...

K024240 is an FDA 510(k) clearance for BD VACUTAINER PLUS PLASTIC URINE C&S PR..., manufactured by Bd. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K024240 · Bd · Microbiology device
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Mar 2003
Decision
93d
Days
Class 1
Risk

K024240 is an FDA 510(k) clearance for the BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on March 26, 2003 after a review of 93 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K024240

510(k) Number K024240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date March 26, 2003
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
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 59
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K024240.
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CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
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A.C.T. I
K965149 · Remel Co. · Jan 1997
A.C.T. IV
K965150 · Remel Co. · Jan 1997