510(k) · Cleared
Recalled · Class I · 2026Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters
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 Jul 30, 2003 as substantially equivalent to K965178 (Vas-Cath, Inc., 1997) and 1 other predicate after a 184-day review. Its family tree reaches back 2 generations to 1987. 1 of the 4 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Jul 30, 2003
- Review
- 184 days
- Class
- Class II
- Product code
- MPB
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K871488 (1987). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis Cath | Vas-Cath of Canada, Ltd. | 1987 | — |
| −1 | K965178 | Niagara Dual Lumen Catheter | Vas-Cath, Inc. | 1997 | — |
| 0 (this device) | K030268 | Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen… | C.R. Bard, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K965178 | Niagara Dual Lumen CatheterSummary page 1…s tfication Panel Gastroenterology and Renal Predicate Devices: (As described above) + Niagara Dual Lumen Catheter K965 178 + Vas-Cath Flexxicon I1 Dual Lumen Dialysis Catheter K914 162 Summary of Change: The modification to t… | 1997 |
| * | K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersSummary page 1…cribed above) + Niagara Dual Lumen Catheter K965 178 + Vas-Cath Flexxicon I1 Dual Lumen Dialysis Catheter K914 162 Summary of Change: The modification to the Short-Term Dialysis Catheters is a change of material, design, and bonding… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2026 | Class I | Z-2985-2026 | Material/Component Contamination | this is a downstream recall of class I recall RES 98777 |
| May 21, 2026 | Class II | Z-2657-2026 | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K965178.
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?
Niagara Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular, subclavian or femoral vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030268: Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030268
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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