510(k) · Cleared
ClearedNiagara Dual Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vas-Cath, Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Aug 19, 1997 as substantially equivalent to K871488 (Vas-Cath of Canada, Ltd., 1987) after a 238-day review. Its family tree reaches back 1 generation to 1987. 2 of the 8 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Aug 19, 1997
- Review
- 238 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871488 (1987). 6 later devices descend from it, 3 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK871488 Vas-Cath Permanent Dual Lumen Hemodialysis CathVas-Cath of Canada, Ltd. · 1987
- This deviceK965178 Niagara Dual Lumen CatheterVas-Cath, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK090102 Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension…C.R. Bard, Inc. · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK102833 Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK030268 Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual…C.R. Bard, Inc. · 2003 · Recalled (Class I)
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002 · cites it directly2descendants
- K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc. · 2009 · cites it directly1descendant
- K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2011 · 2 generations on0descendants
- K022688Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · 2 generations on0descendants
- K030268Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersC.R. Bard, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis Cath | Vas-Cath of Canada, Ltd. | 1987 | — |
| 0 (this device) | K965178 | Niagara Dual Lumen Catheter | Vas-Cath, Inc. | 1997 | — |
| +1 | K012193 | Amc Antimicrobial Pin/Wire Sleeve | Smith & Nephew, Inc. | 2002 | — |
| +1 | K090102 | Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension… | C.R. Bard, Inc. | 2009 | Class I |
| +2 | K102833 | Disposable Hemodialysis Access Catheter Sets | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011 | — |
| +2 | K022688 | Versabond AB Bone Cement | Smith & Nephew, Inc. | 2004 | 1 |
| +1 | K030268 | Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen… | C.R. Bard, Inc. | 2003 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 1 |
| 2004 | 1 | 0 |
| 2009 | 1 | 1 |
| 2011 | 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.
2 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? (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 |
|---|---|---|---|
| * | K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathSummary page 2…(905) 848-5800 Fax (905) 848-6638 K96S |78 @aap Qcé& PVC connectors F. Technological Characteristics: Characteristic Niagara™ Catheter Vas-Cath Soft-Cell™ Catheter (K871488) Shaft Diameter 13.5 French 12.5 French Materials Polyurethane body and Polyurethane body and extensions, extensions, PVC connec… | 1987 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K030268Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersC.R. Bard, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- 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
What does this lineage say?
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) | — |
What is it indicated for?
The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular, subclavian or femoral vein.
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/K965178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965178: Niagara Dual Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965178
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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