510(k) · Cleared

Cleared

Power-Trialysis Triple Lumen Acute Dialysis Catheter

K083675510(k) TraditionalCleared Mar 19, 200998-day reviewClass II21 CFR 876.5540

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. · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Cleared on Mar 19, 2009 as substantially equivalent to K010778 (C.R. Bard, Inc., 2001) and 3 other predicates after a 98-day review. Its family tree reaches back 7 generations to 2000. 7 of the 36 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.

Decided: Mar 19, 2009
Review: 98 days
Class: Class II
Product code: NIE
Recalls: None
Predicates: 4

Its longest line of descent runs back 7 generations to K001901 (2000). 23 ancestors in all, the oldest K830256 (1983). 12 later devices descend from it, 4 citing it directly. 7 of the 36 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
4 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
3 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
2 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
1 generation backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
This deviceK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
Descendant · cites it directly · 7 of its ownK102605 Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Recalled (Class I)
Descendant · cites it directly · 2 of its ownK133456 Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · Recalled (Class I)
Descendant · cites it directly · 2 of its ownK123292 T3Medcomp · 2013
Descendant · 2 generations on · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
Descendant · 2 generations on · 1 of its ownK141531 Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · Recalled (Class I)

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010high 2 (2015) · low 0 (2011)2026

Class I recalls in this family

K020089 Mahurkar Triple Lumen Catheter, 12 FRdirect predicate · 2002
K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…3 generations back · 2000
K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip4 generations back · 1986
K143102 Multi-Lumen Acute Hemodialysis Catheter for High…cites it directly · 2015

Most influential descendants

Showing 5 of 12 · See all

K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · cites it directly7descendants
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · cites it directly2descendants
K123292T3Medcomp · 2013 · cites it directly2descendants
K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 2 generations on1descendant
K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K001901	Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…	C.R. Bard, Inc.	2000	2
−6	K012902	Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…	C.R. Bard, Inc.	2001	—
−5	K031129	Poly Per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard, Inc.	2003	—
−4	K033389	Powerpicc Catheters, Models 3175155, 3175135	C.R. Bard, Inc.	2004	1
−3	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	—
0 (this device)	K083675	Power-Trialysis Triple Lumen Acute Dialysis Catheter	C.R. Bard, Inc.	2009	—
+1	K102605	Mahurkar Triple Lumen Dialysis Catheter	Covidien, LLC, Formerly Registered AS Tyco Healthca	2010	Class I
+1	K133456	Power-Trialysis Short-Term Dialysis Catheter	C.R. Bard, Inc.	2014	Class I
+1	K123292	T3	Medcomp	2013	—
+2	K183219	Trio-CT Triple Lumen Catheter	Medical Components, Inc. (dba MedComp)	2019	—
+2	K141531	Power-Trialysis Slim-Cath Short-Term Dialysis Catheter	C.R. Bard, Inc.	2015	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1986	1	1
1996	1	0
1999	1	0
2000	2	1
2001	3	0
2002	1	1
2003	1	0
2004	1	0
2005	3	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	1
2012	1	0
2013	1	0
2014	1	1
2015	2	2
2016	1	0
2019	1	0
2020	2	0
2023	2	0

FIG. 1 — Lineage of K083675, 2000–2023Source: 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.

7 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 NIE device

#1 K232945 Trio-CT® Triple Lumen Catheter w/ Curved…score 9.4 · 11 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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
*	K010778	Niagara Slim-Cath Summary page 1 …remarket Notification: See below Predicate Device Name I 510(k) Concurrence Date Niagara"' Siim-Cath ® Short K010778 April 13, 2001 Term Dialysis Catheters Trade Name: PowerPICC® Catheters…	C.R. Bard, Inc.	2001	—
*	K053501	Powerpicc Summary page 1 …6 Fr Triple Lumen (TL) PoerIC~cahee PowerPICC ®catheter _ K053501 _ _ _ _…	Bard Access Systems, Inc.	2006	—
*	K051991	Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line Summary page 1 …_ _ _ _ _ _ _ _ _ Central Venous Pressure Monitoring - PICCs and CVC K051991 October 20, 2005 Catheters Trade Name: Mahurkar® Triple Lumen Catheter…	C.R. Bard, Inc.	2005	—
*	K020089	Mahurkar Triple Lumen Catheter, 12 FR Summary page 2 …elow Predicate Device Name 510 (k) Concurrence Date Mahurkar® Triple Lumen K020089 January 9, 2002 Catheter Classification 21 CFR §876.5540(b)(2), Class II,…	The Kendall Company	2002	Class I

Also cleared against K010778: 4 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K102605	Mahurkar Triple Lumen Dialysis Catheter Class I	Covidien, LLC, Formerly Registered AS Tyco Healthca	2010	7
K133456	Power-Trialysis Short-Term Dialysis Catheter Class I	C.R. Bard, Inc.	2014	2
K123292	T3	Medcomp	2013	2
K143102	Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Class I	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)	2015	0

Has anything in its family been recalled? (7 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.

K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002 · Direct predicate · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 12 months on median.
11 of the 23 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K102605 (Covidien, LLC, Formerly Registered AS Tyco Healthca, 2010) has gone furthest, with 7 descendants of its own.
4 other devices also cite its predicate K010778.

How does its category compare?

All NIE devices

NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NIE

2in 2023

2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NIE

Too few NIE 510(k)s in any year since 2007 to give a median.

Recalls per year · NIE

6in 2025

2007high 6 (2025) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NIE

72in 2025

2007high 125 (2024) · low 0 (2007)2025

MAUDE reports naming product code NIE, 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	0	—	0	0
2008	0	—	0	2
2009	1	—	0	3
2010	1	—	0	5
2011	0	—	0	12
2012	0	—	0	9
2013	1	—	0	7
2014	1	—	0	13
2015	2	—	0	7
2016	0	—	0	13
2017	0	—	0	38
2018	1	—	0	88
2019	1	—	1	61
2020	0	—	0	51
2021	0	—	0	61
2022	0	—	1 (1)	119
2023	2	—	0	103
2024	0	—	0	125
2025	0	—	6	72
2026	0	—	3 (1)	—

What is it indicated for?

The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083675 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083675: Power-Trialysis Triple Lumen Acute Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083675

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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