510(k) · Cleared

Recalled · Class II · 2014

Powerpicc Catheters, Models 3175155, 3175135

K033389510(k) TraditionalCleared Mar 19, 2004148-day reviewClass II21 CFR 880.5970Recalls 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. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Cleared on Mar 19, 2004 as substantially equivalent to K031129 (C.R. Bard, Inc., 2003) after a 148-day review. Its family tree reaches back 3 generations to 2000. 15 of the 212 devices in its family, counting itself, have a Class I recall. 208 later devices descend from it. It has been recalled once.

Decided: Mar 19, 2004
Review: 148 days
Class: Class II
Product code: LJS
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K001901 (2000). 208 later devices descend from it, 11 citing it directly. 15 of the 212 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
2 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
1 generation backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
This deviceK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004
Descendant · cites it directly · 199 of its ownK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
Descendant · 2 generations on · 178 of its ownK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
Descendant · cites it directly · 127 of its ownK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
Descendant · 2 generations on · 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

Showing 5 of 208 descendants. See all descendants

Descendants cleared per year

2005high 19 (2007) · low 2 (2024)2026

Class I recalls in this family

K210264 BD PowerPiCC Catheter2 generations on · 2021
K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…3 generations on · 2007
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 208 · See all

K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005 · cites it directly199descendants
K051672PowerpiccBard Access Systems, Inc. · 2005 · 2 generations on178descendants
K050185Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005 · cites it directly127descendants
K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · 2 generations on126descendants
K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · cites it directly119descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
−2	K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…	C.R. Bard, Inc.	2001	—
−1	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	—
0 (this device)	K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard, Inc.	2004	—
+1	K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	—
+2	K051672	Powerpicc	Bard Access Systems, Inc.	2005	1
+1	K050185	Powerhohn and Powerline Catheters	C.R. Bard, Inc.	2005	—
+2	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	7	0
2006	5	0
2007	19	1
2008	10	0
2009	10	0
2010	10	1
2011	9	0
2012	19	3
2013	17	2
2014	15	2
2015	8	2
2016	15	2
2017	8	0
2018	11	0
2019	6	0
2020	9	0
2021	5	1
2022	4	1
2023	5	0
2024	2	0
2025	12	0
2026	2	0

FIG. 1 — Lineage of K033389, 2000–2026Source: 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? (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
*	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc Summary page 4 …Name: Class 11,80 LJS - Long Term lntravascular Catheter Classification Panel: General Hospital Premarket Notification: K03 1129, concurrence (late May 5, 2003 7.4 D)evice l)escription · The PowverPICC Catheters are open-ended radiopaque polyuret…	C.R. Bard, Inc.	2003	—

Also cleared against K031129: 2 other devices →

What descends from it? (208)

See all 208

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

Number	Device	Applicant	Decided	Descendants
K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	199
K050185	Powerhohn and Powerline Catheters	C.R. Bard, Inc.	2005	127
K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	119
K070996	4 FR Single Lumen (SL) Powerpicc Catheter	C.R. Bard, Inc.	2007	66
K053345	Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D	Medcomp	2006	43
K051102	Omnipicc PI	Rita Medical Systems, Inc.	2005	11
K062579	Omnipicc P.I.	Rita Medical Systems, Inc.	2006	10
K071875	V-Cath Poly Picc	Hdc Corp.	2007	9
K041849	Turbo-Flo Picc	Cook, Inc.	2005	8
K102159	Powerpicc SV Catheters	C.R. Bard, Inc.	2010	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 8, 2014	Class II	Z-1271-2015	Nonconforming Material/Component	Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)…

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.

K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
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
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
K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 6 generations on · ◆ in the 2013 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 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K050931 (C.R. Bard, Inc., 2005) has gone furthest, with 199 descendants of its own.
2 other devices also cite its predicate K031129.

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?

The PowerPICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K033389 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033389: Powerpicc Catheters, Models 3175155, 3175135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033389

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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