510(k) · Cleared
ClearedAngiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Apr 19, 2004 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Apr 19, 2004
- Review
- 62 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly. 4 of the 10 devices in this family, counting this one, have a Class I recall.
- This deviceK040402 Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK101843 Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK092597 Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK141363 Centros Long Term Hemodialysis Catheter, Centrosflo Long Term…Merit Medical Systems, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc. · 2007 · cites it directly7descendants
- K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · 2 generations on6descendants
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · cites it directly2descendants
- K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc. · 2009 · cites it directly2descendants
- K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040402 | Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2004 | — |
| +1 | K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR… | Ash Access Technology, Inc. | 2007 | 3 |
| +2 | K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2008 | 5 |
| +1 | K101843 | Duramax Chronic Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2010 | Class I |
| +1 | K092597 | Centros Chronic Hemodialysis Catheter Set | Ash Access Technology, Inc. | 2009 | — |
| +2 | K141363 | Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis… | Merit Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 1 |
| 2011 | 1 | 0 |
| 2014 | 2 | 1 |
| 2016 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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 MSD device
- #1 K241581 Hemodialysis Catheterscore 12.3 · 11 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM… | 2007 | 7 |
| K101843 | Duramax Chronic Hemodialysis Catheter and Procedure Kit Class I | 2010 | 2 |
| K092597 | Centros Chronic Hemodialysis Catheter Set | 2009 | 2 |
| K090148 | Proguide Chronic Dialysis Catheter Class I | 2009 | 0 |
Has anything in its family been recalled? (4 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.
- K090148Proguide Chronic Dialysis CatheterMerit Medical Systems, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K070572 (Ash Access Technology, Inc., 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
MAUDE reports naming product code MSD, 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 | 7 | 92 | 0 | 118 |
| 2008 | 3 | 89 | 47 | 174 |
| 2009 | 6 | 81 | 49 | 173 |
| 2010 | 4 | 116 | 11 | 306 |
| 2011 | 7 | 70 | 24 | 268 |
| 2012 | 2 | — | 0 | 367 |
| 2013 | 5 | 105 | 1 | 363 |
| 2014 | 8 | 246 | 0 | 506 |
| 2015 | 1 | — | 0 | 550 |
| 2016 | 2 | — | 0 | 532 |
| 2017 | 2 | — | 0 | 484 |
| 2018 | 2 | — | 0 | 463 |
| 2019 | 1 | — | 0 | 645 |
| 2020 | 4 | 106 | 0 | 401 |
| 2021 | 4 | 153 | 0 | 523 |
| 2022 | 0 | — | 0 | 610 |
| 2023 | 0 | — | 0 | 542 |
| 2024 | 0 | — | 0 | 841 |
| 2025 | 1 | — | 0 | 1,054 |
| 2026 | 0 | — | 4 (4) | — |
What is it indicated for?
The AngioDynamics, Inc. More-Flow Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative insertion sites include the subclavian vein as required.
Catheters greater than 40cm are intended for femoral vein insertion.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040402: Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040402
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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