510(k) · Cleared

Cleared

6 FR DL Powerpicc Catheter

K050931510(k) SpecialCleared Jun 15, 200562-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 Jun 15, 2005 as substantially equivalent to K033389 (C.R. Bard, Inc., 2004) and 1 other predicate after a 62-day review. Its family tree reaches back 4 generations to 2000. 15 of the 205 devices in its family, counting itself, have a Class I recall. 199 later devices descend from it.

Decided: Jun 15, 2005
Review: 62 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. 199 later devices descend from it, 4 citing it directly. 15 of the 205 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 backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
This deviceK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
Descendant · cites it directly · 178 of its ownK051672 PowerpiccBard Access Systems, 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 · 108 of its ownK053501 PowerpiccBard Access Systems, Inc. · 2006
Descendant · 2 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
Descendant · 2 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled

Showing 5 of 199 descendants. See all descendants

Descendants cleared per year

2005high 19 (2012) · low 2 (2005)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 199 · See all

K051672PowerpiccBard Access Systems, Inc. · 2005 · cites it directly178descendants
K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · cites it directly119descendants
K053501PowerpiccBard Access Systems, Inc. · 2006 · 2 generations on108descendants
K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 2 generations on66descendants
K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 2 generations on66descendants

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	K034019	Poly Per-Q-Cath Picc Catheters	C.R. Bard, Inc.	2004	1
0 (this device)	K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	—
+1	K051672	Powerpicc	Bard Access Systems, 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	K053501	Powerpicc	Bard Access Systems, Inc.	2006	—
+2	K070996	4 FR Single Lumen (SL) Powerpicc Catheter	C.R. Bard, Inc.	2007	—
+2	K060812	Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple	C.R. Bard, Inc.	2006	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	4	0
2007	17	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	14	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 K050931, 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? (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 2 …TM The indications for use have not changed from the predicate 5 Fr SL PowerPICC catheter (K033389). The PowerPICC TM catheter is indicated for short or long term peripheral access to the central venous system for i…	C.R. Bard, Inc.	2004	1
*	K034019	Poly Per-Q-Cath Picc Catheters Summary page 1 …al Name: Peripherally Inserted Central Catheter (PICC) Classification Name: Long Term Intravascular Catheter (80 US) Premrarket Notification: K0340 19, concurrence date - January 21, 2004 6.4 Device Description * The Powerf`ICCW Catheters are open-ended radiopaque p…	C.R. Bard, Inc.	2004	1

Also cleared against K033389: 10 other devices →

What descends from it? (199)

See all 199

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

Number	Device	Applicant	Decided	Descendants
K051672	Powerpicc	Bard Access Systems, Inc.	2005	178
K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	119
K062579	Omnipicc P.I.	Rita Medical Systems, Inc.	2006	10
K072230	Powerpicc Solo	C.R. Bard, Inc.	2007	5

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.

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 5 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K051672 (Bard Access Systems, Inc., 2005) has gone furthest, with 178 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?

The PowerPICC TM 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 as stated in the FDA summary.

https://510kreport.com/device/K050931 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050931: 6 FR DL Powerpicc Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050931

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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