Cleared Special

K041071 - BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041071 · Becton, Dickinson & CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
18d
Days
Class 2
Risk

K041071 is an FDA 510(k) clearance for the BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K.... Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on May 14, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K041071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date May 14, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 235
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