510(k) · Cleared
Recalled · 2008Integral Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Int'L. · MSD Catheter, Hemodialysis, Implanted
Cleared on Mar 5, 2004 as substantially equivalent to K010399 (Diatek, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 2 of the 7 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 15 times.
- Decided
- Mar 5, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 15
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010399 (2001). 5 later devices descend from it, 2 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- This deviceK040260 Integral Hemodialysis CatheterArrow Int'L. · 2004
- Descendant · cites it directly · 3 of its ownK102238 Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK111900 Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK130192 Nextstep RetrogradeArrow International, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK141051 Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K102238Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · cites it directly3descendants
- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · 2 generations on2descendants
- K130192Nextstep RetrogradeArrow International, Inc. · 2013 · 3 generations on1descendant
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…Arrow International, Inc. · 2014 · 3 generations on0descendants
- K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| 0 (this device) | K040260 | Integral Hemodialysis Catheter | Arrow Int'L. | 2004 | — |
| +1 | K102238 | Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | 1 |
| +2 | K111900 | Nextstep Antegrade Chronic Hemodialysis Catheter | Teleflexmedical, Inc. | 2011 | Class I |
| +3 | K130192 | Nextstep Retrograde | Arrow International, Inc. | 2013 | — |
| +3 | K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic… | Arrow International, Inc. | 2014 | Class I |
| +1 | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
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 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 |
|---|---|---|---|
| * | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC…Summary page 1…assification MSD, Class III, 21 CER 876.5540, Catheter, Hemodialysis, name: Implanted Legally marketed Arrow Cannon Catheter (K01 0399). devices to which the device is substantially- equivalent: Description of the The Arrow integral hemodialysis cath… | 2001 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2008 | Not classified | Z-2281-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2271-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2285-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2272-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2278-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2273-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2283-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2276-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2280-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2282-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2277-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2275-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2274-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2284-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
| Jun 10, 2008 | Not classified | Z-2279-2008 | Device Design | The tips may not have been adequately welded to the catheter body. |
The 5 latest of 15 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.
- K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Arrow® integral catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The integral catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The integral catheter is intended for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040260: Integral Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040260
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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