Cleared Traditional

K163001 - PowerFlow Apheresis I.V. Port (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163001 · C.R. Bard, Inc. · General Hospital
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Apr 2017
Decision
171d
Days
Class 2
Risk

K163001 is an FDA 510(k) clearance for the PowerFlow Apheresis I.V. Port. Classified as Subcutaneous Implanted Apheresis Port (product code PTD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 17, 2017 after a review of 171 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K163001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date April 17, 2017
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 128d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTD Subcutaneous Implanted Apheresis Port
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
Definition A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis
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.