510(k) · Cleared
ClearedZenysis 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. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Jan 5, 2016 as substantially equivalent to K010778 (C.R. Bard, Inc., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 10 generations to 2000. 5 of the 27 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 5, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K001901 (2000). 26 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 5 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- 2 generations backK133456 Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · Recalled (Class I)
- 1 generation backK141531 Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · Recalled (Class I)
- This deviceK153190 Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 3 generations backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- 2 generations backK133456 Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · Recalled (Class I)
- 1 generation backK141531 Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · Recalled (Class I)
- This deviceK153190 Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2016
Class I recalls in this family
- K141531 Power-Trialysis Slim-Cath Short-Term Dialysis…direct predicate · 2015
- K133456 Power-Trialysis Short-Term Dialysis Catheter2 generations back · 2014
- K020089 Mahurkar Triple Lumen Catheter, 12 FR4 generations back · 2002
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…6 generations back · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −5 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −4 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −3 | K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard, Inc. | 2009 | — |
| −2 | K133456 | Power-Trialysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2014 | Class I |
| −1 | K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2015 | Class I |
| 0 (this device) | 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 |
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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K010778 | Niagara Slim-CathSummary page 4…§876.5540 Trade Name: Niagara™ Slim-Cath Short-Term Dialysis Catheters Predicate Classification Name: Short-Term Hemodialysis Catheter Devices Premarket Notification: KO010778 Manufacturer: Bard Access Systems, Inc. Trade Name: Power-Trialysis™ Slim-Cath™ Short-Term Dialysis Catheter R(I;fg‘l;(ie:ece Cla… | 2001 |
| * | K141531 | Power-Trialysis Slim-Cath Short-Term Dialysis CatheterSummary page 4…Power-Trialysis™ Slim-Cath™ Short-Term Dialysis Catheter R(I;fg‘l;(ie:ece Classification Name: Short-Term Hemodialysis Catheter Premarket Notification: Manufacturer: K141531 Bard Access Systems, Inc. 16 K153190 Page 2 of 4 Device Description Zenysis™ Short-Term Dialysis Catheters are… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002 · 4 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 · 6 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 · 7 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 12 months on median.
- 13 of the 26 ancestors have a recall of any class; 5 have a Class I recall.
- 4 other devices also cite its predicate K010778.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
The Zenysis™ Short-Term Dialysis Catheter, 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.
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/K153190 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153190: Zenysis Short-Term Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153190
Report an extraction error
Are you the manufacturer?
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