Cleared Traditional

K150059 - BD FlowSmart Set

K150059 is an FDA 510(k) clearance for BD FlowSmart Set, manufactured by Becton, Dickinson Company. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K150059 · Becton, Dickinson Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
105d
Days
Class 2
Risk

K150059 is an FDA 510(k) clearance for the BD FlowSmart Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Becton, Dickinson Company (Franklin Lakes, US). The FDA issued a Cleared decision on April 28, 2015 after a review of 105 days - within the typical 510(k) review window.

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 Company devices

FDA 510(k) Submission Details - K150059

510(k) Number K150059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2015
Decision Date April 28, 2015
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 770
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K150059.
Accu-Chek FlexLink Plus infusion set
K143446 · Roche Diagnostics GmbH · Aug 2015
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K143082 · B.Braun Medical, Inc. · Jul 2015
Imed Technology Intravascular Administration Set, Imed Technology Extension Set
K150513 · Imed Technology, Inc. · May 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · Baxter Healthcare Corporation · Apr 2015
Hospira Blood Set
K143087 · Hospira, Inc. · Mar 2015
Hospira Primary Sets
K143015 · Hospira, Inc. · Feb 2015