Cleared Traditional

K013621 - BD SAF-T PRN LUER ACTIVATED VALVE

K013621 is an FDA 510(k) clearance for BD SAF-T PRN LUER ACTIVATED VALVE, manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K013621 · Becton Dickinson Infusion Therapy Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
162d
Days
Class 2
Risk

K013621 is an FDA 510(k) clearance for the BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on April 16, 2002 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K013621

510(k) Number K013621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date April 16, 2002
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K013621.
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SIMPLICITY SIMPLEX SOFT INFUSION SET
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