510(k) · Cleared

Cleared

Powerhohn and Powerline Catheters

K050185510(k) TraditionalCleared May 26, 2005119-day reviewClass II21 CFR 880.5970

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. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on May 26, 2005 as substantially equivalent to K033389 (C.R. Bard, Inc., 2004) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 2000. 15 of the 133 devices in its family, counting itself, have a Class I recall. 127 later devices descend from it.

Decided: May 26, 2005
Review: 119 days
Class: Class II
Product code: LJS
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K001901 (2000). 5 ancestors in all, the oldest K830256 (1983). 127 later devices descend from it, 4 citing it directly. 15 of the 133 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
3 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
2 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
1 generation backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
This deviceK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
Descendant · cites it directly · 126 of its ownK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
Descendant · cites it directly · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
Descendant · 2 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
Descendant · cites it directly · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
Descendant · 2 generations on · 43 of its ownK053345 Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 2006 · Recalled

Showing 5 of 127 descendants. See all descendants

Descendants cleared per year

2005high 16 (2012) · low 0 (2024)2026

Class I recalls in this family

K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…2 generations on · 2007
K210264 BD PowerPiCC Catheter3 generations on · 2021
K113277 Arrowadvantages Pressure Injectable Peripherally…3 generations on · 2012
K143102 Multi-Lumen Acute Hemodialysis Catheter for High…3 generations on · 2015

Most influential descendants

Showing 5 of 127 · See all

K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · cites it directly126descendants
K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · cites it directly119descendants
K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 2 generations on66descendants
K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · cites it directly47descendants
K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp · 2006 · 2 generations on43descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
−3	K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…	C.R. Bard, Inc.	2001	—
−2	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	—
−1	K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard, Inc.	2004	1
0 (this device)	K050185	Powerhohn and Powerline Catheters	C.R. Bard, Inc.	2005	—
+1	K051417	6 FR FL Powerhohn and Powerline Catheter	C.R. Bard, Inc.	2005	1
+1	K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	—
+2	K070996	4 FR Single Lumen (SL) Powerpicc Catheter	C.R. Bard, Inc.	2007	—
+1	K061179	Powerhickman Long-Term Intravascular Catheter	C.R. Bard, Inc.	2006	—
+2	K053345	Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D	Medcomp	2006	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	3	0
2007	7	1
2008	2	0
2009	7	0
2010	6	1
2011	4	0
2012	16	3
2013	13	2
2014	12	2
2015	7	2
2016	13	2
2017	4	0
2018	8	0
2019	4	0
2020	6	0
2021	1	1
2022	3	1
2023	3	0
2025	6	0

FIG. 1 — Lineage of K050185, 2000–2025Source: 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.

15 devices in this family have a Class I recall. 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 LJS device

#1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K033389	Powerpicc Catheters, Models 3175155, 3175135 Summary page 1 …Classification Name: Class II, 80 LJS - Long Term Intravascular Catheter Classification Panel: General Hospital Premarket Notification: K033389, Substantial Equivalence: April 14, 2004 Device Name: Broviac® Catheter Trade Name:…	C.R. Bard, Inc.	2004	1
*	K830256	Non-Sterile Broviac Parenteral Alimi- Summary page 1 …Classification Name: Class 11, 80 LIS - Long Term Intravascular Catheter Classification Panel: General Hospital Premarket Notification: K830256, Substantial Equivalence: March 1, 1983…	Evermed, Inc.	1983	1

Also cleared against K033389: 10 other devices →

What descends from it? (127)

See all 127

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

Number	Device	Applicant	Decided	Descendants
K051417	6 FR FL Powerhohn and Powerline Catheter	C.R. Bard, Inc.	2005	126
K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	119
K061179	Powerhickman Long-Term Intravascular Catheter	C.R. Bard, Inc.	2006	47
K093927	6F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…	C.R. Bard, Inc.	2010	6

Has anything in its family been recalled? (15 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 12 of 15 shown.

Nearest 5 of 15; all are on the web page.

What does this lineage say?

The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K051417 (C.R. Bard, Inc., 2005) has gone furthest, with 126 descendants of its own.
10 other devices also cite its predicate K033389.

How does its category compare?

All LJS devices

LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJS

8in 2025

2007high 16 (2009) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJS

171in 2025

2007high 284 (2021) · low 31 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJS

5in 2023

2007high 40 (2012) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · LJS

4,372in 2025

2007high 4,372 (2025) · low 369 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	92	0	392
2008	4	97	1	369
2009	16	70	1	379
2010	9	114	12	495
2011	6	55	4	696
2012	14	77	40	564
2013	14	31	0	680
2014	8	47	15	842
2015	7	71	2	1,306
2016	9	128	18	1,123
2017	7	101	9	2,100
2018	10	148	3	2,324
2019	0	—	0	2,052
2020	2	—	0	2,539
2021	3	284	1	3,084
2022	3	177	0	3,256
2023	4	47	5 (2)	2,799
2024	1	—	0	4,243
2025	8	171	0	4,372
2026	2	—	8 (1)	—

What is it indicated for?

PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050185 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050185: Powerhohn and Powerline Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050185

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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