510(k) · Decided
Recalled · 2009Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spire Biomedical, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Dec 23, 2003 as substantially equivalent to K013160 (Spire Biomedical, Inc., 2002) after a 173-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it. It has been recalled 48 times.
- Decided
- Dec 23, 2003
- Review
- 173 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 48
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013160 (2002). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- This deviceK032061 Decathlon Twin Lumen Hemodialysis with Separated Tips, Models…Spire Biomedical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK042858 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated…Spire Biomedical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK040509 Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24…Spire Biomedical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK073092 Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK063441 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24…Spire Biomedical, Inc. · 2007 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K04285855CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated TipsSpire Biomedical, Inc. · 2004 · cites it directly1descendant
- K040509Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32…Spire Biomedical, Inc. · 2004 · cites it directly1descendant
- K073092Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24…Spire Biomedical, Inc. · 2008 · cites it directly0descendants
- K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32…Spire Biomedical, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| 0 (this device) | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH… | Spire Biomedical, Inc. | 2003 | — |
| +1 | K042858 | 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips | Spire Biomedical, Inc. | 2004 | 48 |
| +1 | K040509 | Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28… | Spire Biomedical, Inc. | 2004 | 48 |
| +1 | K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models… | Spire Biomedical, Inc. | 2008 | — |
| +2 | K063441 | 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28… | Spire Biomedical, Inc. | 2007 | 48 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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.
Planning a device in MSD? 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? (3)
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 |
|---|---|---|---|
| * | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSummary page 2…tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressOTM catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split CathTM. The polyurethane… | 2002 |
| * | — | Medical Components, Inc. Ash Split Cath Named without a submission number | |
| * | — | Kendall Healthcare Maxid Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042858 | 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips | 2004 | 1 |
| K040509 | Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32… | 2004 | 1 |
| K073092 | Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24… | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2009 | Not classified | Z-0288-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0289-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0290-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0299-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0301-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0302-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0304-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0306-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0309-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0311-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0312-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0294-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0295-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0296-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0297-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0300-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0303-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0307-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0308-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0314-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0316-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0317-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0318-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0319-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0321-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0330-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0291-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0292-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0293-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0298-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0305-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0310-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0313-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0315-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0320-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0322-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0323-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0324-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0325-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0327-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0328-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0332-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0334-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0335-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0329-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0331-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0333-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0326-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
The 5 latest of 48 recalls; the web page lists all.
No ancestor or descendant has a 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
2007high 8 (2014) · low 0 (2022)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
2007high 246 (2014) · low 70 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
2007high 49 (2009) · low 0 (2007)2026
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
2007high 1,054 (2025) · low 118 (2007)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 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032061: Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032061
Report an extraction error
Are you the manufacturer?
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