510(k) · Decided
Recalled · Class I · 2026Power-Trialysis Short-Term Dialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Sep 24, 2014 as substantially equivalent to K083675 (C.R. Bard, Inc., 2009) after a 316-day review. Its family tree reaches back 8 generations to 2000. 5 of the 27 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Sep 24, 2014
- Review
- 316 days
- Class
- Class II
- Product code
- NIE
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001901 (2000). 24 ancestors in all, the oldest K830256 (1983). 2 later devices descend from it, 1 citing it directly. 5 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 1 generation backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- This deviceK133456 Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK141531 Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK153190 Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2016
Class I recalls in this family
- K020089 Mahurkar Triple Lumen Catheter, 12 FR2 generations back · 2002
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…4 generations back · 2000
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip5 generations back · 1986
- K141531 Power-Trialysis Slim-Cath Short-Term Dialysis…cites it directly · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −3 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −1 | K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard, Inc. | 2009 | — |
| 0 (this device) | K133456 | Power-Trialysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2014 | — |
| +1 | K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2015 | Class I |
| +2 | K153190 | Zenysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2016 | — |
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 |
|---|---|---|
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
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.
5 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 9.3 · 11 generations · no Class I recall
- #2 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K083675 | Power-Trialysis Triple Lumen Acute Dialysis CatheterSummary page 5…icate Product Code: NIE Device Classification Regulation: 21 CFR §876.5540 Premarket Notification: K083675 Concurrence Date: March 19, 2009 ™ Power-Trialysis Short… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis Catheter Class I | 2015 | 1 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2026 | Class I | Z-2984-2026 | Material/Component Contamination | this is a downstream recall of class I recall RES 98777 |
| May 21, 2026 | Class II | Z-2660-2026 | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Sep 16, 2019 | Class II | Z-0285-2020 | Under Investigation by firm | A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter. |
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 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 4 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 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 11 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K141531 (C.R. Bard, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K083675.
How does its category compare?
All NIE devicesNIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NIE
2in 2023
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
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NIE
72in 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-Trialysis 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/K133456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133456: Power-Trialysis Short-Term Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133456
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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