510(k) · Cleared

Cleared

Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100

K012902510(k) SpecialCleared Sep 10, 200112-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 Sep 10, 2001 as substantially equivalent to K001901 (C.R. Bard, Inc., 2000) after a 12-day review. Its family tree reaches back 1 generation to 2000. 16 of the 249 devices in its family, counting itself, have a Class I recall. 247 later devices descend from it.

Decided: Sep 10, 2001
Review: 12 days
Class: Class II
Product code: LJS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001901 (2000). 247 later devices descend from it, 1 citing it directly. 16 of the 249 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
This deviceK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
Descendant · cites it directly · 246 of its ownK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
Descendant · 2 generations on · 239 of its ownK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
Descendant · 2 generations on · 208 of its ownK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
Descendant · 3 generations on · 199 of its ownK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
Descendant · 4 generations on · 178 of its ownK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled

Showing 5 of 247 descendants. See all descendants

Descendants cleared per year

2003high 20 (2012) · low 1 (2003)2026

Class I recalls in this family

K210264 BD PowerPiCC Catheter4 generations on · 2021
K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…5 generations on · 2007
K113277 Arrowadvantages Pressure Injectable Peripherally…5 generations on · 2012
K143102 Multi-Lumen Acute Hemodialysis Catheter for High…5 generations on · 2015

Most influential descendants

Showing 5 of 247 · See all

K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003 · cites it directly246descendants
K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · 2 generations on239descendants
K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · 2 generations on208descendants
K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005 · 3 generations on199descendants
K051672PowerpiccBard Access Systems, Inc. · 2005 · 4 generations on178descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
0 (this device)	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	—
+2	K034019	Poly Per-Q-Cath Picc Catheters	C.R. Bard, Inc.	2004	1
+2	K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard, Inc.	2004	1
+3	K050931	6 FR DL Powerpicc Catheter	C.R. Bard, Inc.	2005	—
+4	K051672	Powerpicc	Bard Access Systems, Inc.	2005	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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	18	2
2015	12	2
2016	16	3
2017	11	0
2018	13	0
2019	6	0
2020	9	0
2021	6	1
2022	6	1
2023	5	0
2024	3	0
2025	16	0
2026	3	0

FIG. 1 — Lineage of K012902, 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.

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? (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
*	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model… Summary page 1 …) Trade Name: Poly Per-Q-Cath PICC Catheter Common/Usual Name: Poly Per-Q-Cath PICC Classification Name: Long Term Intravascular Catheter (80LJS) Premarket Notification: K001901, cleared for marketing on September 19, 2000 4. Device Description The Poly Per-Q-Cath PICC Single and Dual Lumen Catheters are…	C.R. Bard, Inc.	2000	2

Also cleared against K001901: 2 other devices →

What descends from it? (247)

See all 247

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	246

Has anything in its family been recalled? (16 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 · 4 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 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 5 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 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 5 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 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 6 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 · 6 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 · 7 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 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 8 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?

Its one ancestor has a recall.
Of its descendants, K031129 (C.R. Bard, Inc., 2003) has gone furthest, with 246 descendants of its own.
2 other devices also cite its predicate K001901.

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

https://510kreport.com/device/K012902 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012902: Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012902

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026