Cleared Special

K033350 - BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER (FDA 510(k) Clearance)

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

K033350 · Becton, Dickinson & CO · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2003
Decision
29d
Days
Class 2
Risk

K033350 is an FDA 510(k) clearance for the BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on November 18, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device 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 K033350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2003
Decision Date November 18, 2003
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

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