510(k) · Cleared

Cleared

6 FR Poly Per-Q-Cath Triple Lumen Picc

K043502510(k) SpecialCleared Jan 14, 200525-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 Jan 14, 2005 as substantially equivalent to K034019 (C.R. Bard, Inc., 2004) after a 25-day review. Its family tree reaches back 4 generations to 2000. 15 of the 138 devices in its family, counting itself, have a Class I recall. 133 later devices descend from it.

Decided: Jan 14, 2005
Review: 25 days
Class: Class II
Product code: LJS
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K001901 (2000). 133 later devices descend from it, 4 citing it directly. 15 of the 138 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 deviceK043502 6 FR Poly Per-Q-Cath Triple Lumen PiccC.R. Bard, Inc. · 2005
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 · cites it directly · 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 · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
Descendant · 2 generations on · 31 of its ownK081904 Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full…Medcomp · 2008 · Recalled

Showing 5 of 133 descendants. See all descendants

Descendants cleared per year

2005high 17 (2012) · low 0 (2024)2026

Class I recalls in this family

K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…3 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 133 · See all

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 · cites it directly108descendants
K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 2 generations on66descendants
K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 2 generations on47descendants
K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp · 2008 · 2 generations on31descendants

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)	K043502	6 FR Poly Per-Q-Cath Triple Lumen Picc	C.R. Bard, Inc.	2005	—
+1	K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	—
+1	K053501	Powerpicc	Bard Access Systems, Inc.	2006	—
+2	K070996	4 FR Single Lumen (SL) Powerpicc Catheter	C.R. Bard, Inc.	2007	—
+2	K061179	Powerhickman Long-Term Intravascular Catheter	C.R. Bard, Inc.	2006	—
+2	K081904	Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)	Medcomp	2008	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	6	1
2008	3	0
2009	8	0
2010	8	1
2011	4	0
2012	17	3
2013	13	2
2014	12	2
2015	7	2
2016	13	2
2017	4	0
2018	9	0
2019	5	0
2020	6	0
2021	2	1
2022	3	1
2023	3	0
2025	6	0

FIG. 1 — Lineage of K043502, 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? (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
*	K034019	Poly Per-Q-Cath Picc Catheters Summary page 1 …e: Peripherally Inserted Central Catheter (P1CC) Classification Name: Long Term Intravascular Catheter (80 LJS) Prermarket Notification: K034019, concurrence nate -- January 2 1, 2004 6.4 Device Description Principle of Operation There are no new operati…	C.R. Bard, Inc.	2004	1

Also cleared against K034019: 5 other devices →

What descends from it? (133)

See all 133

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

Number	Device	Applicant	Decided	Descendants
K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line	C.R. Bard, Inc.	2005	119
K053501	Powerpicc	Bard Access Systems, Inc.	2006	108
K091586	Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen	Medcomp	2009	9
K102159	Powerpicc SV Catheters	C.R. Bard, Inc.	2010	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.

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
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
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 12 months on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K051991 (C.R. Bard, Inc., 2005) has gone furthest, with 119 descendants of its own.
5 other devices also cite its predicate K034019.

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 Poly Per-Q-Cath®3 Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043502 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043502: 6 FR Poly Per-Q-Cath Triple Lumen Picc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043502

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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