510(k) · Cleared
ClearedNiagara Slim-Cath
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 Apr 13, 2001 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 19 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it.
- Decided
- Apr 13, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 5 citing it directly. 5 of the 19 devices in this family, counting this one, have a Class I recall.
- This deviceK010778 Niagara Slim-CathC.R. Bard, Inc. · 2001
- Descendant · cites it directly · 12 of its ownK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK102605 Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK133456 Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK123292 T3Medcomp · 2013
- Descendant · 3 generations on · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009 · cites it directly12descendants
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 2 generations on7descendants
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 2 generations on2descendants
- K123292T3Medcomp · 2013 · 2 generations on2descendants
- K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010778 | Niagara Slim-Cath | C.R. Bard, Inc. | 2001 | — |
| +1 | K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard, Inc. | 2009 | — |
| +2 | K102605 | Mahurkar Triple Lumen Dialysis Catheter | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | Class I |
| +2 | K133456 | Power-Trialysis Short-Term Dialysis Catheter | C.R. Bard, Inc. | 2014 | Class I |
| +2 | K123292 | T3 | Medcomp | 2013 | — |
| +3 | K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 2 | 1 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 2 | 2 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | 2009 | 12 |
| K090102 | Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis Catheters Class I | 2009 | 1 |
| K040301 | Gamcath High Flow Catheter, Ref: GDHK 13XX a | 2004 | 1 |
| K163458 | Zenysis Short-Term Dialysis Catheter | 2017 | 0 |
| K153190 | Zenysis Short-Term Dialysis Catheter | 2016 | 0 |
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.
- K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 2 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 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K083675 (C.R. Bard, Inc., 2009) has gone furthest, with 12 descendants of its own.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K010778 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010778: Niagara Slim-Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010778
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026