510(k) · Cleared

Recalled · Class II · 2026

Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135

K001901510(k) TraditionalCleared Sep 19, 200089-day reviewClass II21 CFR 880.5970Recalls 2

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 Sep 19, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 of the 251 devices in its family, counting itself, have a Class I recall. 250 later devices descend from it. It has been recalled 2 times.

Decided: Sep 19, 2000
Review: 89 days
Class: Class II
Product code: LJS
Recalls: 2
Predicates: 0

250 later devices descend from it, 3 citing it directly. 16 of the 251 devices in this family, counting this one, have a Class I recall.

This deviceK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000
Descendant · cites it directly · 247 of its ownK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
Descendant · 2 generations on · 246 of its ownK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
Descendant · 3 generations on · 239 of its ownK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
Descendant · 3 generations on · 208 of its ownK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
Descendant · 4 generations on · 199 of its ownK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005

Showing 5 of 250 descendants. See all descendants

Descendants cleared per year

2001high 20 (2012) · low 0 (2002)2026

Class I recalls in this family

K210264 BD PowerPiCC Catheter5 generations on · 2021
K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…6 generations on · 2007
K113277 Arrowadvantages Pressure Injectable Peripherally…6 generations on · 2012
K143102 Multi-Lumen Acute Hemodialysis Catheter for High…6 generations on · 2015

Most influential descendants

Showing 5 of 250 · See all

K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen…C.R. Bard, Inc. · 2001 · cites it directly247descendants
K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003 · 2 generations on246descendants
K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · 3 generations on239descendants
K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · 3 generations on208descendants
K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005 · 4 generations on199descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	—
+1	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	—
+3	K034019	Poly Per-Q-Cath Picc Catheters	C.R. Bard, Inc.	2004	1
+3	K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard, Inc.	2004	1
+4	K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2004	2	0
2005	8	0
2006	7	0
2007	19	1
2008	12	0
2009	11	0
2010	13	1
2011	12	0
2012	20	3
2013	18	2
2014	19	2
2015	12	2
2016	16	3
2017	11	0
2018	13	0
2019	6	0
2020	9	0
2021	6	1
2022	7	1
2023	5	0
2024	3	0
2025	16	0
2026	3	0

FIG. 1 — Lineage of K001901, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

16 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (250)

See all 250

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

Number	Device	Applicant	Decided	Descendants
K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen…	C.R. Bard, Inc.	2001	247
K091586	Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen	Medcomp	2009	9
K141026	Leaderflex	Vygon	2014	1

Has anything in its family been recalled? (16 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 21, 2026	Class II	Z-2656-2026	Nonconforming Material/Component	Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
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 · 5 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 · 6 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 6 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 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 6 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 · 6 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 7 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 · 7 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 · 8 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 · 8 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 9 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

Nearest 12 of 16 shown.

Nearest 5 of 16; all are on the web page.

What does this lineage say?

Of its descendants, K012902 (C.R. Bard, Inc., 2001) has gone furthest, with 247 descendants of its own.

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)	—

https://510kreport.com/device/K001901 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001901: Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001901

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026