510(k) · Cleared

Cleared

PowerFlow Implantable Apheresis IV Port

K191143510(k) TraditionalCleared Aug 2, 201994-day reviewClass II21 CFR 880.5965

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 Aug 2, 2019 as substantially equivalent to K163001 (C.R. Bard, Inc., 2017) after a 94-day review. Its family tree reaches back 2 generations to 1995.

Decided: Aug 2, 2019
Review: 94 days
Class: Class II
Product code: PTD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K926139 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926139 Cathlink 20 Titanium Port W/Att. Polyurethane CathBard Access Systems, Inc. · 1995
1 generation backK163001 PowerFlow Apheresis I.V. PortC.R. Bard, Inc. · 2017 · Recalled
This deviceK191143 PowerFlow Implantable Apheresis IV PortC.R. Bard, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926139	Cathlink 20 Titanium Port W/Att. Polyurethane Cath	Bard Access Systems, Inc.	1995	—
−1	K163001	PowerFlow Apheresis I.V. Port	C.R. Bard, Inc.	2017	1
0 (this device)	K191143	PowerFlow Implantable Apheresis IV Port	C.R. Bard, Inc.	2019	—

FIG. 1 — Lineage of K191143, 1995–2019Source: 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
*	K163001	PowerFlow Apheresis I.V. Port Summary page 4 …Classification Name: Subcutaneous, implanted, intravascular infusion port and catheter Premarket Notification: K163001 Regulatory Class: Class 2 Product Code: PTD Regulation Number: 21 CFR §880.…	C.R. Bard, Inc.	2017	1

Also cleared against K163001: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 22.3 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K163001.

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. 2019, 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, IV 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/K191143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191143: PowerFlow Implantable Apheresis IV Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191143

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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