510(k) · Decided
Recalled · Class II · 2024Duraflow 2 Chronic 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 Jun 10, 2011 as substantially equivalent to K101843 (AngioDynamics, Inc., 2010) after a 67-day review. Its family tree reaches back 8 generations to 1998. 1 of the 17 devices in its family, counting itself, has a Class I recall. It has been recalled 6 times.
- Decided
- Jun 10, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 8 generations to K981994 (1998). 16 ancestors in all, the oldest K972207 (1998). No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
- 7 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
- 6 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
- 5 generations backK022678 Medcomp SC4Medcomp · 2003
- 4 generations backK040318 Medcomp Split-Cath IIMedcomp · 2005
- 3 generations backK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- 2 generations backK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- 1 generation backK101843 Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · Recalled (Class I)
- This deviceK110936 Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2011
Class I recalls in this family
- K101843 Duramax Chronic Hemodialysis Catheter and…direct predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981994 | Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter | C.R. Bard, Inc. | 1998 | — |
| −7 | K012562 | Medcomp 14.5F Double Lumen Hemodialysis Catheter | Medical Components, Inc. | 2002 | — |
| −6 | K020465 | Medcomp Ash Split-Cath II | Medcomp | 2002 | — |
| −5 | K022678 | Medcomp SC4 | Medcomp | 2003 | — |
| −4 | K040318 | Medcomp Split-Cath II | Medcomp | 2005 | — |
| −3 | 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 |
| 0 (this device) | K110936 | Duraflow 2 Chronic Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K101843 | Duramax Chronic Hemodialysis Catheter and Procedure KitSummary page 1…ing device: Device Namie -- I Manufacturer 510(k) No. Angil~ynamnics DuraMaxV Catheter and AngloDynamic K 101843, cleared Procedure Kit 1sT… | 2010 |
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 |
|---|---|---|---|---|
| Mar 18, 2024 | Class II | Z-1762-2024 | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Mar 18, 2024 | Class II | Z-1765-2024 | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Mar 18, 2024 | Class II | Z-1761-2024 | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Mar 18, 2024 | Class II | Z-1763-2024 | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Mar 18, 2024 | Class II | Z-1760-2024 | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Mar 18, 2024 | Class II | Z-1764-2024 | Under Investigation by firm | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K101843.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit 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 40 cm are intended for femoral vein insertion.
This catheter is indicated for > 30 days long-term placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110936: Duraflow 2 Chronic 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/K110936
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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