510(k) · Cleared

Recalled · Class II · 2019

PowerFlow Apheresis I.V. Port

K163001510(k) TraditionalCleared Apr 17, 2017171-day reviewClass II21 CFR 880.5965Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · PTD Subcutaneous Implanted Apheresis Port

Cleared on Apr 17, 2017 as substantially equivalent to K926139 (Bard Access Systems, Inc., 1995) after a 171-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.

Decided: Apr 17, 2017
Review: 171 days
Class: Class II
Product code: PTD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K926139 (1995). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK926139 Cathlink 20 Titanium Port W/Att. Polyurethane CathBard Access Systems, Inc. · 1995
This deviceK163001 PowerFlow Apheresis I.V. PortC.R. Bard, Inc. · 2017
Descendant · cites it directly · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Descendant · cites it directly · 0 of its ownK191143 PowerFlow Implantable Apheresis IV PortC.R. Bard, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all

K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · cites it directly0descendants
K191143PowerFlow Implantable Apheresis IV PortC.R. Bard, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926139	Cathlink 20 Titanium Port W/Att. Polyurethane Cath	Bard Access Systems, Inc.	1995	—
0 (this device)	K163001	PowerFlow Apheresis I.V. Port	C.R. Bard, Inc.	2017	—
+1	K192291	TidalPort-AP Implantable Apheresis Vascular Access Port	Norfolk Medical Products, Inc.	2020	—
+1	K191143	PowerFlow Implantable Apheresis IV Port	C.R. Bard, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	1	0

FIG. 1 — Lineage of K163001, 1995–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PTD device

#1 K192291 TidalPort-AP Implantable Apheresis Vascular…score 3.5 · 13 generations · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K926139	Cathlink 20 Titanium Port W/Att. Polyurethane Cath Summary page 4 …Titanium Port with Attachable Polyurethane Catheter Classification Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Premarket Notification: K926139 Manufacturer: Bard Access Systems, Inc. This predicate has not been subject to a design-related recall. === Page 5…	Bard Access Systems, Inc.	1995	—
†	K041088	Trifusion, Model 0609190/0659350	C.R. Bard, Inc.	2004	—
†	K072215	Titanium Powerport Isp Implanted Port	C.R. Bard, Inc.	2007	—

Also cleared against K926139: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K192291	TidalPort-AP Implantable Apheresis Vascular Access Port	Norfolk Medical Products, Inc.	2020	0
K191143	PowerFlow Implantable Apheresis IV Port	C.R. Bard, Inc.	2019	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 1, 2019	Class II	Z-1579-2020	Component change control	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K192291 (Norfolk Medical Products, Inc., 2020) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K926139.

How does its category compare?

All PTD devices

PTD Subcutaneous Implanted Apheresis Port: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · PTD

1in 2020

2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PTD

Too few PTD 510(k)s in any year since 2007 to give a median.

Recalls per year · PTD

No recall names PTD since 2007.

Adverse event reports per year · PTD

26in 2025

2007high 35 (2019) · low 0 (2007)2025

MAUDE reports naming product code PTD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	4
2018	0	—	15
2019	1	—	35
2020	1	—	18
2021	0	—	15
2022	0	—	11
2023	0	—	25
2024	0	—	22
2025	0	—	26
2026	0	—	—

What is it indicated for?

The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products.

The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163001 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163001: PowerFlow Apheresis I.V. Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163001

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026